TRE ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症554

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05147805
(ClinicalTrials.gov)
March 31, 202224/11/2021A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial HypertensionA Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil Palmitil;Drug: PlaceboInsmed IncorporatedNULLRecruiting18 Years75 YearsAll99Phase 2United States
2NCT04972656
(ClinicalTrials.gov)
March 5, 20229/7/2021Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial HypertensionTreatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled StudyPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: PlaceboNanjing First Hospital, Nanjing Medical UniversityTianjin Medical University General HospitalNot yet recruiting18 YearsN/AAll420N/ANULL
3EUCTR2020-005061-13-NL
(EUCTR)
09/02/202225/11/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
4EUCTR2020-005061-13-PL
(EUCTR)
26/01/202202/12/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
5EUCTR2020-005061-13-SE
(EUCTR)
10/01/202212/10/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Brazil;Belgium;Poland;Croatia;United States;Portugal;Serbia;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Germany;New Zealand;Sweden
6EUCTR2021-003020-32-ES
(EUCTR)
03/01/202219/10/2021A Phase 2 Study of Sotatercept for Combined Postcapillary and Precapillary Pulmonary Hypertension TreatmentPhase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) - A Phase 2 Study of Sotatercept for Cpc-PH Treatment Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved EjectionFraction (HFpEF)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: SOTATERCEPT
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
7EUCTR2021-004002-21-AT
(EUCTR)
26/11/202106/09/2021A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH) pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: 20 mg/ml Treprostinil
INN or Proposed INN: treprostinil sodium
Other descriptive name: TREPROSTINIL SODIUM
Trade Name: Trisuva(r)
Product Name: Trisuva(r)
INN or Proposed INN: treprostinil sodium
Other descriptive name: TREPROSTINIL SODIUM
AOP Orphan Pharmaceuticals GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Austria
8EUCTR2019-002533-11-BG
(EUCTR)
08/11/202102/09/2021A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Japan;Sweden
9EUCTR2020-005061-13-ES
(EUCTR)
06/07/202108/07/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
10EUCTR2020-005169-15-ES
(EUCTR)
28/06/202105/07/2021Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Serbia;Czechia;Canada;Belgium;Spain;Austria;Australia;Israel;Germany;United Kingdom
11EUCTR2020-004142-11-PL
(EUCTR)
24/06/202123/03/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
12JPRN-jRCT2061200058
23/06/202119/02/2021Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS Pulmonary Arterial HypertensionMacitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally.
Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally.
Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally.
Placebo: Participants will receive matching placebo film-coated tablets orally.
Nakano MasayoshiNULLRecruiting>= 18age oldNot applicableBoth900Phase 3Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Korea, Republic Of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Japan;Argentina;Australia;Austria;Belarus
13EUCTR2020-004142-11-IT
(EUCTR)
23/06/202108/06/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - - Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: [ACE-011]
ACCELERON PHARMA INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Korea, Democratic People's Republic of;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
14EUCTR2017-003934-10-PL
(EUCTR)
23/06/202126/07/2019A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies.mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 3France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany
15EUCTR2020-005061-13-DE
(EUCTR)
22/06/202124/02/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
16EUCTR2020-005169-15-CZ
(EUCTR)
17/06/202107/04/2021Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2- YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany
17NCT04451850
(ClinicalTrials.gov)
June 1, 202125/6/2020HRV as a Marker of Treatment Response in PAH Arterial HypertensionHeart Rate Variability (HRV) as a Marker of Treatment Response in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionOther: Noninvasive actigraphy monitorUniversity of CincinnatiNULLRecruiting18 Years70 YearsAll35United States
18NCT04791514
(ClinicalTrials.gov)
May 31, 20218/3/2021Open Label Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil PalmitilInsmed IncorporatedNULLRecruiting18 YearsN/AAll10Phase 2United States
19EUCTR2020-004142-11-DE
(EUCTR)
12/05/202119/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
20NCT04796337
(ClinicalTrials.gov)
May 12, 202122/2/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAHPAHBiological: sotaterceptAcceleron Pharma Inc.NULLRecruiting18 YearsN/AAll700Phase 3United States;Australia;Brazil;France;Germany;Israel;Spain
21EUCTR2019-002669-37-BE
(EUCTR)
04/05/202118/01/2021Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany
22EUCTR2019-002817-21-FI
(EUCTR)
16/04/202111/02/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden
23EUCTR2020-004142-11-BE
(EUCTR)
15/04/202108/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
24NCT04816604
(ClinicalTrials.gov)
April 5, 202123/3/2021Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: GB002 (seralutinib);Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years80 YearsAll100Phase 2United States;France;Germany;Spain
25EUCTR2020-004142-11-SE
(EUCTR)
26/03/202128/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
26EUCTR2020-004142-11-NL
(EUCTR)
24/03/202117/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
27NCT04576988
(ClinicalTrials.gov)
January 25, 202128/9/2020A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAHPulmonary Arterial HypertensionDrug: Sotatercept;Drug: PlaceboAcceleron Pharma Inc.NULLActive, not recruiting18 YearsN/AAll284Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Israel;Mexico;New Zealand;Poland;Serbia;Spain;Sweden;Switzerland;United Kingdom
28EUCTR2019-002669-37-CZ
(EUCTR)
21/01/202122/10/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany
29EUCTR2019-002669-37-DE
(EUCTR)
07/01/202128/07/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany
30EUCTR2019-002669-37-AT
(EUCTR)
15/12/202007/08/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Serbia;United States;Czechia;Spain;Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany
31NCT04456998
(ClinicalTrials.gov)
December 14, 202030/6/2020GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Artery HypertensionDrug: GB002 (seralutinib);Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLRecruiting18 Years75 YearsAll80Phase 2United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Israel;Serbia;Spain;United Kingdom
32EUCTR2019-004131-24-GB
(EUCTR)
23/11/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
33EUCTR2019-002533-11-SK
(EUCTR)
12/11/202013/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden
34EUCTR2019-002533-11-AT
(EUCTR)
12/11/202004/09/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
35EUCTR2019-004131-24-LT
(EUCTR)
10/11/202022/09/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
36EUCTR2019-002533-11-NO
(EUCTR)
29/10/202003/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden
37JPRN-JapicCTI-194971
23/10/202025/09/2019Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH)Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy pulmonary arterial hypertensionIntervention name : ACT-064992D
INN of the intervention : -
Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments.
Control intervention name : Macitentan
INN of the control intervention : -
Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily.
Control intervention name : Tadalafil
INN of the control intervention : -
Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH170Phase 3Japan, South America, Europe
38NCT04589390
(ClinicalTrials.gov)
October 15, 20208/10/2020Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionSelexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial HypertensionPulmonary Hypertension;SchistosomiasisDrug: SelexipagUniversity of Sao Paulo General HospitalJanssen-Cilag Ltd.Recruiting18 YearsN/AAll20Phase 2Brazil
39EUCTR2019-002669-37-GB
(EUCTR)
08/10/202011/05/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Serbia;France;Austria;Australia;Israel;Germany;United Kingdom;Canada;Belgium;Singapore
40NCT04567602
(ClinicalTrials.gov)
October 6, 202023/9/2020A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or SelexipagNon-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)Pulmonary Arterial HypertensionDrug: PAH medicationJanssen-Cilag S.p.A.NULLRecruiting18 YearsN/AAll200Italy
41EUCTR2019-002669-37-FR
(EUCTR)
01/10/202015/07/2020Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: Seralutinib
Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Serbia;France;Canada;Belgium;Singapore;Austria;Australia;Israel;Germany;United Kingdom
42EUCTR2019-002533-11-NL
(EUCTR)
29/09/202029/04/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
655Phase 3United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Japan;Sweden
43EUCTR2020-002788-80-DE
(EUCTR)
09/09/202008/06/2020Study to evaluate the safety, tolerability and efficacy of AZD4831 in thetreatment of patients with pulmonary hypertensionAn explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH) Group 1: Pulmonary arterial hypertension (PAH)Group 2: Postcapillary pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: AZD4831University of CologneNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Germany
44EUCTR2019-002533-11-PT
(EUCTR)
31/08/202011/05/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden
45EUCTR2019-002817-21-LT
(EUCTR)
13/08/202025/05/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
46EUCTR2019-004131-24-DE
(EUCTR)
10/08/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
47NCT03833323
(ClinicalTrials.gov)
August 1, 20205/2/2019Implantable System for Remodulin Post-Approval StudyImplantable System for Remodulin Post-Approval StudyPulmonary Arterial HypertensionCombination Product: Implantable System for Remodulin (treprostinil)Medtronic Cardiac Rhythm and Heart FailureUnited TherapeuticsWithdrawn22 YearsN/AAll0NULL
48EUCTR2019-004131-24-HU
(EUCTR)
27/07/202028/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
49EUCTR2019-002817-21-PT
(EUCTR)
27/07/202006/02/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Belarus;Portugal;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden
50EUCTR2019-004131-24-PL
(EUCTR)
02/07/202002/06/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
51EUCTR2019-004131-24-IT
(EUCTR)
01/07/202014/06/2021A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: [JNJ-67896062/ ACT-064992]
INN or Proposed INN: MACITENTAN
Product Name: MACITENTAN TABLETS
Product Code: [JNJ-67896062 / ACT-064992]
INN or Proposed INN: MACITENTAN
Product Name: MACITENTAN COMPRESSE
Product Code: [JNJ-67896062 / ACT-064992]
INN or Proposed INN: MACITENTAN
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
52EUCTR2019-002533-11-GB
(EUCTR)
30/06/202016/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden;United Kingdom;Austria;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Vietnam;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Thailand;Slovakia;Taiwan;Portugal;Belarus;Serbia;United States
53NCT04273945
(ClinicalTrials.gov)
June 30, 202031/1/2020Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial HypertensionA Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mgPulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: PlaceboActelionNULLRecruiting18 YearsN/AAll900Phase 3United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Brazil;Romania
54EUCTR2019-002533-11-DE
(EUCTR)
17/06/202014/02/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Taiwan;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden;Czech Republic;United Kingdom;Austria;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Vietnam;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Thailand;Slovakia;Portugal;Belarus;Serbia;United States
55EUCTR2019-004131-24-ES
(EUCTR)
05/06/202020/07/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
56EUCTR2019-002533-11-DK
(EUCTR)
27/05/202031/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden
57EUCTR2019-002533-11-HU
(EUCTR)
10/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden;Hungary;Czech Republic;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Italy;Russian Federation;Israel;Ukraine;Spain;Thailand;Taiwan;Portugal;United States
58EUCTR2019-002533-11-CZ
(EUCTR)
07/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
59EUCTR2019-002533-11-SE
(EUCTR)
06/05/202013/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
60EUCTR2019-002817-21-IT
(EUCTR)
22/04/202017/06/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel- Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: [JNJ-67896049 (ACT-293987)]
Product Name: Selexipag
Product Code: [JNJ-67896049 (ACT-293987)]
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Sweden
61EUCTR2019-002817-21-DE
(EUCTR)
16/04/202030/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
62EUCTR2019-002533-11-IT
(EUCTR)
15/04/202015/06/2021A Randomized Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period with Macitentan 75 mg.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan tablets
Product Code: [JNJ-67896062 / ACT-064992]
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: [JNJ-67896062 / ACT-064992]
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: [JNJ-67896062 / ACT-064992]
INN or Proposed INN: MACITENTAN
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden
63NCT04309838
(ClinicalTrials.gov)
March 202020/2/2020Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial HypertensionLENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;PAHCombination Product: Treprostinil via implanted pumpUniversity Medicine GreifswaldOMT GmbH & Co. KGNot yet recruiting18 YearsN/AAll30Germany
64EUCTR2019-002817-21-BG
(EUCTR)
11/02/202006/01/2020A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;Taiwan;Spain;United States;Belarus;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden
65EUCTR2019-002817-21-HU
(EUCTR)
05/02/202029/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
237Phase 3Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
66NCT03926793
(ClinicalTrials.gov)
February 4, 202022/4/2019Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial HypertensionA Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLCompleted18 Years75 YearsAll8Phase 1United States;United Kingdom
67NCT04175600
(ClinicalTrials.gov)
January 16, 20208/11/2019A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial HypertensionA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting2 Years17 YearsAll237Phase 3United States;Australia;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Croatia;Finland;France;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;Vietnam;Argentina;Austria;Denmark;Romania
68EUCTR2019-002817-21-ES
(EUCTR)
07/01/202011/11/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
237 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
69EUCTR2019-002414-40-GB
(EUCTR)
17/12/201924/10/2019An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension (PAH).
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: CXA-10
Product Code: CXA-10
INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid
Complexa Inc.NULLNot RecruitingFemale: yes
Male: yes
115Phase 2United States;United Kingdom
70EUCTR2018-002796-18-IT
(EUCTR)
28/11/201929/01/2021To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease - Safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: zamicastat
Product Code: [BIA-5-1058]
INN or Proposed INN: zamicastat
BIAL-Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
71NCT03884465
(ClinicalTrials.gov)
November 11, 20194/3/2019Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of TreprostinilA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) SubjectsPulmonary Arterial HypertensionDrug: Inhaled dry powder treprostinil (LIQ861)Liquidia Technologies, Inc.FGK Clinical Research GmbHRecruiting18 YearsN/AAll32Phase 2France;Germany
72EUCTR2018-002448-10-DE
(EUCTR)
08/11/201917/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;France;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
73EUCTR2018-002448-10-IT
(EUCTR)
29/10/201901/02/2021Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: zamicastat
Product Code: [BIA 5-1058]
INN or Proposed INN: zamicastat
BIAL-Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
74EUCTR2014-004786-25-BG
(EUCTR)
11/10/201901/07/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan
75NCT03950739
(ClinicalTrials.gov)
September 17, 20199/5/2019Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoAn Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using TyvasoPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderUnited TherapeuticsNULLActive, not recruiting18 YearsN/AAll51Phase 1United States
76EUCTR2014-004786-25-DE
(EUCTR)
05/09/201902/05/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan
77EUCTR2018-001187-33-PT
(EUCTR)
02/09/201922/03/2019A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
78EUCTR2018-003093-27-GB
(EUCTR)
16/08/201912/06/2019Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH)A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GB002 Capsules
Product Code: GB002
INN or Proposed INN: GB002
GB002, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
16 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;United Kingdom;Sweden
79EUCTR2014-004786-25-ES
(EUCTR)
13/08/201911/06/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-064992D
INN or Proposed INN: MACITENTAN
INN or Proposed INN: TADALAFIL
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China
80EUCTR2014-004786-25-PL
(EUCTR)
10/08/201928/05/2019A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan
81EUCTR2014-004786-25-IT
(EUCTR)
06/08/201917/06/2021A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH).Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy - Nap Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: CJNJ-68150420-ZZZ-G001 (ACT- 064992D)
Product Code: [CJNJ-68150420-ZZZ-G001 (ACT- 064992D)]
INN or Proposed INN: MACITENTAN
Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera
INN or Proposed INN: TADALAFIL
Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera
Trade Name: Adcirca®
Product Name: G04BE08
Product Code: [G04BE08]
INN or Proposed INN: TADALAFIL
Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera
Trade Name: Opsumit®
Product Name: macitentan
Product Code: [ACT-064992]
INN or Proposed INN: MACITENTAN
ACTELION PHARMACEUTICALS LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan
82NCT04055415
(ClinicalTrials.gov)
August 1, 20198/8/2019Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial HypertensionSafety and Efficacy of Transplantation of Adipose Derived Mesenchymal Stem Cells to Treat Pulmonary Arterial HypertensionPulmonary HypertensionBiological: adipose derived mesenchymal stem cells;Drug: Conventional drug therapy(expectorant,bronchodilator)Liaocheng People's HospitalNULLRecruiting40 Years75 YearsAll60Phase 1/Phase 2China
83EUCTR2018-002796-18-PT
(EUCTR)
30/07/201930/10/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
84NCT03904693
(ClinicalTrials.gov)
July 29, 20194/4/2019Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination TherapyPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafilActelionNULLRecruiting18 YearsN/AAll170Phase 3United States;Australia;Brazil;Bulgaria;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey
85NCT03992755
(ClinicalTrials.gov)
July 18, 20195/6/2019Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of TreprostinilA Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Active, not recruiting18 YearsN/AAll92Phase 3United States
86EUCTR2018-001187-33-HR
(EUCTR)
20/05/201905/06/2019 A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Arena Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Sweden;Japan;Germany;Bulgaria;Croatia;Singapore;Brazil;Belgium;Argentina;Canada;Mexico;European Union;Hungary;United Kingdom;Turkey
87EUCTR2016-001067-36-PL
(EUCTR)
08/05/201918/02/2019A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
88NCT03835676
(ClinicalTrials.gov)
May 1, 20196/2/2019Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionEffects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: TreprostinilMagdi H. YacoubNULLRecruiting18 YearsN/AAll30Phase 4Egypt
89NCT03738150
(ClinicalTrials.gov)
May 1, 20192/11/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionA Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionBiological: SotaterceptAcceleron Pharma Inc.NULLActive, not recruiting18 YearsN/AAll21Phase 2United States
90EUCTR2018-001187-33-NL
(EUCTR)
16/04/201918/12/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
91EUCTR2018-001187-33-BG
(EUCTR)
10/04/201913/12/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Croatia;Bulgaria;Germany;Sweden;Singapore;Belgium;Poland;Brazil;Argentina;Canada;European Union;Mexico;Hungary;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Denmark;Australia;Chile;Israel;Ukraine;Greece;Taiwan;United States;Serbia;Portugal
92EUCTR2018-001187-33-GB
(EUCTR)
03/04/201931/10/2018 A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
93EUCTR2018-001187-33-GR
(EUCTR)
03/04/201920/03/2019A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to ImproveTreatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
94NCT04062565
(ClinicalTrials.gov)
March 25, 201929/3/2019Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAHA Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810)Pulmonary Arterial HypertensionDrug: Treprostinil Injectable Product;Drug: Riociguat PillUniversity of ArizonaNULLRecruiting18 YearsN/AAll20Phase 3United States
95EUCTR2018-001187-33-DE
(EUCTR)
18/03/201929/10/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
96EUCTR2018-002796-18-GB
(EUCTR)
12/03/201919/06/2019To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial HypertensionAn open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease. - Safety and efficacy of BIA 5-1058 in PAH Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: Zamicastat
Bial - Portela & Ca, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
97JPRN-JapicCTI-194651
12/3/201905/03/2019MD-711 Phase 2/3 Study in PAHMD-711 Phase 2/3 Study in Pulmonary Arterial Hypertension Pulmonary arterial hypertensionIntervention name : MD-711
INN of the intervention : treprostinil
Dosage And administration of the intervention : Inhaled admistration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Mochida Pharmaceutical Co., Ltd.NULLcomplete1875BOTH15Phase 2-3Japan
98EUCTR2018-001187-33-BE
(EUCTR)
18/02/201910/12/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden
99EUCTR2018-001187-33-SE
(EUCTR)
05/02/201929/10/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
100EUCTR2018-003414-40-DE
(EUCTR)
31/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 26.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 53 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 79.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 106 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: Nitric Oxide
INN or Proposed INN: NITRIC OXIDE
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
101EUCTR2018-001187-33-DK
(EUCTR)
29/01/201926/11/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients (ADVANCE Outcomes) - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
102EUCTR2018-003414-40-FR
(EUCTR)
21/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 25 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 50 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 75 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 100 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
103NCT03754660
(ClinicalTrials.gov)
January 21, 201923/11/2018This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592Hypertension, PulmonaryDrug: BAY1237592BayerNULLRecruiting18 Years80 YearsAll56Phase 1Austria;Czechia;Germany;Poland
104EUCTR2018-002796-18-ES
(EUCTR)
17/01/201916/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Spain;Ukraine;Austria;United Kingdom
105EUCTR2018-001187-33-PL
(EUCTR)
16/01/201906/12/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
106EUCTR2018-001187-33-HU
(EUCTR)
14/01/201906/11/2018A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.A Study Evaluating the EffiCacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
107EUCTR2017-004738-27-BE
(EUCTR)
04/01/201931/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom
108EUCTR2018-002796-18-AT
(EUCTR)
20/12/201806/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
109EUCTR2018-002448-10-PT
(EUCTR)
26/11/201804/09/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy
110EUCTR2018-002448-10-ES
(EUCTR)
21/11/201809/10/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria
111NCT04041648
(ClinicalTrials.gov)
November 9, 201823/7/2019Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy SubjectsPulmonary Arterial HypertensionDrug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug;Device: L606 Inhalation System;Other: Placebo SolutionPharmosa Biopharm Inc.PPDRecruiting18 Years50 YearsAll64Phase 1United States
112EUCTR2018-002448-10-AT
(EUCTR)
31/10/201808/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
113EUCTR2017-004738-27-GB
(EUCTR)
18/10/201824/06/2019A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
114NCT03528902
(ClinicalTrials.gov)
October 1, 201821/3/2018Tamoxifen Therapy to Treat Pulmonary Arterial HypertensionTamoxifen Therapy to Treat Pulmonary Arterial HypertensionHypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Tamoxifen;Estrogen Receptor Antagonist;Hormone Antagonists;EstrogensDrug: Tamoxifen;Drug: Placebo Oral TabletVanderbilt University Medical CenterNULLRecruiting18 YearsN/AAll24Phase 2United States
115EUCTR2017-000216-42-FR
(EUCTR)
27/09/201823/07/2018Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden
116NCT03497689
(ClinicalTrials.gov)
September 21, 201820/3/2018EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionEXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Intravenous/Subcutaneous Treprostinil; Oral TreprostinilUnited TherapeuticsNULLRecruiting17 Years85 YearsAll35Phase 4United States
117EUCTR2017-004738-27-ES
(EUCTR)
04/09/201805/09/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
118NCT03626688
(ClinicalTrials.gov)
August 30, 201827/7/2018A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAHPAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNULLRecruiting18 YearsN/AAll700Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Serbia;Singapore;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom
119EUCTR2017-004738-27-DE
(EUCTR)
15/08/201803/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom
120NCT03496207
(ClinicalTrials.gov)
June 27, 201829/3/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma Inc.NULLActive, not recruiting18 YearsN/AAll106Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom
121NCT03683082
(ClinicalTrials.gov)
June 5, 201820/9/2018Oxygen Treatment and Pulmonary Arterial HypertensionAcute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Oxygen supplementation;Drug: Sham O2 (medical air)George Papanicolaou HospitalNULLUnknown status18 Years80 YearsAll10N/AGreece
122EUCTR2017-000216-42-PT
(EUCTR)
14/05/201803/11/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
123NCT03422328
(ClinicalTrials.gov)
April 5, 201830/1/2018A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical StudiesPulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: macitentanActelionNULLEnrolling by invitationN/AN/AAll150Phase 3Belarus;Belgium;France;Poland;Russian Federation;Ukraine
124EUCTR2017-003934-10-FR
(EUCTR)
19/03/201819/01/2018A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
125NCT03464864
(ClinicalTrials.gov)
March 9, 20181/3/2018Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal VolunteersA Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal VolunteersPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderMannkind CorporationNULLCompleted18 Years55 YearsAll36Phase 1United States
126NCT03362047
(ClinicalTrials.gov)
March 1, 201822/11/2017(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen BedingungenPulmonary Arterial Hypertension (PAH)Drug: Riciguat Group;Drug: Macitentan GroupUniversity of GiessenPhilipps University Marburg Medical CenterRecruiting18 Years85 YearsAll30Phase 2Germany
127NCT03399604
(ClinicalTrials.gov)
January 2, 20183/1/2018Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilA Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Completed18 YearsN/AAll121Phase 3United States
128EUCTR2017-000137-31-NL
(EUCTR)
19/12/201719/07/2017Treatment of Pulmonary Hypertension with 6 MercaptopurinePulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MP Pulmonary arterial hypertension
MedDRA version: 20.0;Level: HLGT;Classification code 10037454;Term: Pulmonary vascular disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Puri-NetholVU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands
129EUCTR2017-000216-42-DE
(EUCTR)
30/11/201726/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
130EUCTR2017-000216-42-SE
(EUCTR)
24/10/201716/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
131NCT02999906
(ClinicalTrials.gov)
October 201719/12/2016Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Oral Treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years79 YearsAll0Phase 3NULL
132NCT03001414
(ClinicalTrials.gov)
September 28, 201715/12/2016Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCsA Multicentre, Late Phase Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional TreatmentsHypertension,PulmonaryBiological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOSNorthern TherapeuticsOttawa Hospital Research InstituteRecruiting18 Years80 YearsAll45Phase 2/Phase 3Canada
133NCT02927366
(ClinicalTrials.gov)
September 19, 20175/10/2016Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH PatientsA Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: QCC374;Drug: Placebo MatchingNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 2United States;Germany;Korea, Republic of;United Kingdom;Taiwan
134EUCTR2017-000216-42-IE
(EUCTR)
12/09/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
135EUCTR2017-000212-41-DE
(EUCTR)
01/09/201727/06/2017Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH)An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GSK2586881
Product Code: GSK2586881
INN or Proposed INN: GSK2586881
Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Spain;Germany
136EUCTR2017-000216-42-AT
(EUCTR)
29/08/201709/06/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
137EUCTR2017-000212-41-ES
(EUCTR)
10/08/201722/06/2017Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH).An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GSK2586881
Product Code: GSK2586881
INN or Proposed INN: GSK2586881
Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Germany
138EUCTR2016-001412-38-DE
(EUCTR)
27/07/201703/04/2017Safety, pharmacokinetics and efficacy study of QCC374 in PAH patientsA randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QCC374 0.015 mg
INN or Proposed INN: TBD
Product Code: QCC374 0.06 mg
INN or Proposed INN: TBD
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
139NCT03045029
(ClinicalTrials.gov)
July 18, 20172/2/2017ADAPT - A Patient Registry of the Real-world Use of Orenitram®ADAPT - A Patient Registry of the Real-world Use of Orenitram®Pulmonary Arterial HypertensionDrug: Oral treprostinilUnited TherapeuticsNULLRecruiting18 YearsN/AAll300United States
140EUCTR2017-000216-42-GB
(EUCTR)
11/07/201705/05/2017Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagA multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden
141NCT02800941
(ClinicalTrials.gov)
July 5, 201710/6/2016Bleeding Frequency Under Anticoagulant Treatment in Pulmonary HypertensionBleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.Pulmonary Arterial HypertensionDrug: Oral anticoagulant treatmentCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll203France
142EUCTR2014-003952-29-BE
(EUCTR)
07/06/201703/01/2017Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
143NCT02882126
(ClinicalTrials.gov)
June 201724/8/2016An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionAn Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003Pulmonary Arterial HypertensionDrug: Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
144NCT03016468
(ClinicalTrials.gov)
May 20176/1/2017Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHA Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Parenteral Remodulin (treprostinil) injection;Drug: Oral TreprostinilUnited TherapeuticsNULLWithdrawn18 Years75 YearsAll0Phase 2NULL
145EUCTR2016-001067-36-DE
(EUCTR)
22/03/201710/11/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
146EUCTR2016-001067-36-DK
(EUCTR)
15/03/201723/12/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
147EUCTR2016-001067-36-GR
(EUCTR)
02/03/201717/01/2017A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
148EUCTR2016-001067-36-NL
(EUCTR)
23/02/201707/12/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
149EUCTR2016-001067-36-BE
(EUCTR)
20/02/201714/11/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
150NCT02893995
(ClinicalTrials.gov)
February 201724/8/2016Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionA 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Withdrawn18 YearsN/AAll0Phase 4China
151EUCTR2016-001067-36-CZ
(EUCTR)
19/01/201713/10/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
152NCT02891850
(ClinicalTrials.gov)
January 11, 201726/8/2016Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapyA Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment GoalPulmonary Arterial HypertensionDrug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: TadalafilBayerNULLCompleted18 Years75 YearsAll225Phase 4United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland
153NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
154EUCTR2016-001067-36-PT
(EUCTR)
29/12/201613/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Tadalafil
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
155EUCTR2016-001067-36-GB
(EUCTR)
21/12/201624/10/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Tadalafil
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
156EUCTR2016-001067-36-IT
(EUCTR)
12/12/201605/11/2020A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.0
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 1.5 mg
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 0.5 mg compressa rivestita con film
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.0 mg
INN or Proposed INN: Riociguat
Other descriptive name: Riociguat
Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
Product Name: Adempas¿ 2.5 mg
INN or Proposed INN: Riociguat
BAYER AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland;New Zealand;Japan;Germany;Poland;Belgium;Brazil;Canada;Mexico;Czech Republic;United Kingdom;Austria;Turkey;Czechia;Korea, Republic of;Netherlands;Australia;Denmark;France
157EUCTR2016-001067-36-ES
(EUCTR)
21/11/201609/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
158EUCTR2016-001067-36-AT
(EUCTR)
10/11/201620/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
159EUCTR2014-003952-29-PL
(EUCTR)
28/07/201613/04/2016Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan
160NCT02885012
(ClinicalTrials.gov)
June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
161EUCTR2014-003952-29-DE
(EUCTR)
21/04/201610/08/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Taiwan;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Japan
162EUCTR2014-003952-29-ES
(EUCTR)
01/04/201617/02/2016Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer Healthcare AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy
163EUCTR2012-000098-21-PL
(EUCTR)
27/02/201620/01/2016An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of;Greece;United States;Taiwan
164EUCTR2012-000097-26-PL
(EUCTR)
27/02/201620/01/2016International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
165EUCTR2015-002835-17-DE
(EUCTR)
18/01/201626/11/2015RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatmentInvestigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III Pulmonary arterial Hypertension (PAH)
MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Adempas®
INN or Proposed INN: RIOCIGUAT
Trade Name: Opsumit®
INN or Proposed INN: MACITENTAN
Justus Liebig Universität GießenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
166NCT02676947
(ClinicalTrials.gov)
January 201621/12/2015A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionA Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TocilizumabPapworth Hospital NHS Foundation TrustRoche Pharma AG;National Institute for Health Research, United KingdomCompleted18 Years70 YearsAll29Phase 2United Kingdom
167EUCTR2012-004411-31-GB
(EUCTR)
25/11/201512/06/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Germany;Bulgaria;Romania;Singapore;Poland;Belgium
168EUCTR2014-003952-29-GB
(EUCTR)
25/11/201527/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
169EUCTR2012-000098-21-FR
(EUCTR)
24/11/201526/09/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 15.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Germany;Netherlands;Sweden;Korea, Republic of
170NCT02471183
(ClinicalTrials.gov)
November 4, 201511/6/2015Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNULLCompleted18 Years75 YearsAll30Phase 3United States
171EUCTR2015-002799-26-GB
(EUCTR)
27/10/201521/09/2015A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertensionTRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: n/a
Papworth Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
26Phase 2United Kingdom
172EUCTR2012-004411-31-CZ
(EUCTR)
01/10/201512/12/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
173NCT02576002
(ClinicalTrials.gov)
October 201513/10/2015Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the USHypertension, PulmonaryDrug: Assigned pulmonary hypertension medicationBayerNULLCompletedN/A18 YearsBoth2691N/AUnited States
174NCT02545465
(ClinicalTrials.gov)
September 15, 20158/9/2015A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical PracticeRetrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to AdempasHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompletedN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
175EUCTR2014-003952-29-IT
(EUCTR)
09/09/201515/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer Healthcare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain;Turkey;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Germany;Netherlands;Japan
176EUCTR2014-003952-29-HU
(EUCTR)
25/08/201506/07/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
177EUCTR2012-004411-31-GR
(EUCTR)
19/03/201529/04/2015Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
178JPRN-JapicCTI-142722
01/1/201527/11/2014ACT-385781A extension study for PAH pediatric patientsOpen-label, long-term, efficacy, safety, and tolerability extension study using ACT-385781A in the treatment of Japanese children with pulmonary arterial hypertension who completed the AC-066A308 study. Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : epoprostenol
Dosage And administration of the intervention : continuous intravenous infusion
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH3Phase 3NULL
179NCT02276872
(ClinicalTrials.gov)
December 18, 201421/10/2014Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 YearsA Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial HypertensionPAHDrug: oral treprostinilUnited TherapeuticsNULLCompleted7 Years17 YearsAll32Phase 2United States
180EUCTR2014-001882-28-DE
(EUCTR)
13/10/201407/08/2014Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Volibris
Product Name: Ambrisentan
Thoraxklinik-Heidelberg gGmbHNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
181EUCTR2013-001759-10-GB
(EUCTR)
29/09/201427/08/2014Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: Adempas 0.5 mg Film Coated Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1 mg Film Coated Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg Film Coated Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2 mg Film Coated Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg Film Coated Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;Switzerland;United Kingdom
182NCT02191137
(ClinicalTrials.gov)
September 23, 201427/6/2014Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active TreatmentHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years80 YearsAll75Phase 4United States;Puerto Rico
183EUCTR2012-003335-33-GR
(EUCTR)
22/09/201425/06/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
184EUCTR2012-000097-26-GR
(EUCTR)
05/08/201411/06/2014International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden;United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India
185EUCTR2012-000098-21-GR
(EUCTR)
05/08/201410/06/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
186EUCTR2012-000098-21-DK
(EUCTR)
31/07/201422/05/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
187EUCTR2012-000097-26-DK
(EUCTR)
31/07/201422/05/2014International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
188EUCTR2012-004411-31-RO
(EUCTR)
18/07/201413/05/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Italy;Vietnam;India
189NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
190ChiCTR-TRC-14004894
2014-07-012014-06-30Clinical research on treatment of pulmonary arterial hypertension associated with connective tissue disease by Mycophenolate mofetilClinical research on treatment of pulmonary arterial hypertension associated with connective tissue pulmonary arterial hypertension associated with connective tissue diseaseA:Glucocorticoid plus sildenafil;B:Glucocorticoid plus sildenafil;Beijing Chaoyang Hospital affiliated to Capital Medical UniversityNULLRecruiting1880MaleA:8;B:8;NULL
191EUCTR2012-000098-21-BE
(EUCTR)
18/06/201414/04/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Australia;Peru;Netherlands;Germany;China;Korea, Republic of;Sweden
192EUCTR2012-000097-26-BE
(EUCTR)
18/06/201414/04/2014International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostin
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden
193EUCTR2012-000097-26-SE
(EUCTR)
09/06/201410/04/2014International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
850 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
194EUCTR2012-000098-21-SE
(EUCTR)
15/05/201410/04/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
195NCT02007629
(ClinicalTrials.gov)
February 18, 20146/12/2013Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 InhibitorAn Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i)Hypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years75 YearsAll61Phase 3United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic
196NCT01824290
(ClinicalTrials.gov)
February 5, 20141/4/2013A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Tadalafil;Drug: Placebo;Drug: ERA as specific PAH treatmentEli Lilly and CompanyNULLCompleted6 Months17 YearsAll35Phase 3United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland
197EUCTR2012-004411-31-HU
(EUCTR)
28/01/201429/11/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
198EUCTR2013-001759-10-CZ
(EUCTR)
23/01/201424/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
199NCT02042014
(ClinicalTrials.gov)
January 22, 201417/1/2014Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanAn Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 TreatmentSevere Pulmonary Arterial HypertensionDrug: QTI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll8Phase 3Japan
200EUCTR2013-001759-10-IT
(EUCTR)
14/01/201428/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland;Italy
201EUCTR2013-001759-10-FR
(EUCTR)
06/01/201428/09/2015Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;France;Czech Republic;Canada;Belgium;Germany;United Kingdom;Italy;Switzerland
202EUCTR2013-001759-10-DE
(EUCTR)
03/01/201415/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
203JPRN-JapicCTI-142462
01/1/201403/03/2014An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatmentAn open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment pulmonary arterial hypertensionIntervention name : QTI571
INN of the intervention : imatinib
Dosage And administration of the intervention : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day
Novartis Pharma K.K.NULLBOTHPhase 3NULL
204EUCTR2013-001759-10-BE
(EUCTR)
20/12/201320/11/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
205EUCTR2012-003335-33-CZ
(EUCTR)
04/12/201316/08/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
206EUCTR2012-003335-33-HU
(EUCTR)
26/11/201330/04/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
207EUCTR2013-001100-10-ES
(EUCTR)
12/11/201312/11/2013This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment.An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
81United States;Spain;Australia;Switzerland
208NCT03638908
(ClinicalTrials.gov)
November 201312/7/2018Fluoxetine in Pulmonary Arterial Hypertension (PAH) TrialA Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNULLCompleted16 Years80 YearsAll8Phase 2United States
209EUCTR2009-014992-31-GB
(EUCTR)
28/10/201317/03/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
210EUCTR2012-002354-23-NL
(EUCTR)
18/10/201331/05/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Belgium;Poland;Romania;Netherlands;Germany;Japan
211EUCTR2012-004411-31-ES
(EUCTR)
07/10/201308/10/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 16.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany
212EUCTR2012-004411-31-DE
(EUCTR)
07/10/201325/06/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain
213EUCTR2012-003335-33-NL
(EUCTR)
01/10/201307/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
214NCT01827059
(ClinicalTrials.gov)
October 20135/4/2013Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasEA Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to PlaceboPulmonary Arterial Hypertension;Congenital Heart DiseaseDrug: Bosentan;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)NULLActive, not recruiting18 YearsN/AAll12Phase 2Netherlands
215NCT01894035
(ClinicalTrials.gov)
September 23, 20133/7/2013Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for InhalationStudy to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.Pulmonary HypertensionDrug: Iloprost (Ventavis, BAYQ 6256)BayerNULLCompleted18 YearsN/AAll13Portugal
216EUCTR2012-002354-23-FR
(EUCTR)
23/08/201324/09/2015A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
217EUCTR2012-002354-23-BE
(EUCTR)
19/08/201325/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
218JPRN-JapicCTI-132155
01/8/201311/06/2013Bosentan extension study for PAH pediatric patientsOpen-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. Pulmonary arterial hypertension (PAH)Intervention name : Ro 47-0203 / ACT-050088
INN of the intervention : bosentan
Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d.
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH5Phase 3NULL
219NCT01934582
(ClinicalTrials.gov)
August 201329/8/2013A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolA Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 ProtocolPulmonary Arterial HypertensionDrug: UT-15C SR;Drug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted12 Years75 YearsAll13Phase 3United States
220EUCTR2012-004411-31-AT
(EUCTR)
30/07/201301/07/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Philippines;Taiwan;Greece;Serbia;Portugal;United States
221EUCTR2012-004411-31-BG
(EUCTR)
17/07/201315/05/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Greece;Germany;Bulgaria;Romania;Singapore;Poland;Belgium;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;China;Netherlands;South Africa;Malaysia;France;Vietnam;Italy;Israel;Chile;Russian Federation;Spain
222EUCTR2012-002354-23-RO
(EUCTR)
17/07/201323/07/2014A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
223EUCTR2012-004411-31-PT
(EUCTR)
03/07/201301/07/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Germany;Bulgaria;Romania;Singapore;Belgium;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;China;Netherlands
224NCT01897740
(ClinicalTrials.gov)
July 20138/7/2013Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With SildenafilA LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATIONPulmonary Arterial HypertensionDrug: sildenafilPfizerNULLNo longer available10 Years30 YearsAllRussian Federation
225EUCTR2012-002354-23-DE
(EUCTR)
18/06/201312/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Brazil;Belgium;Poland;Romania;Germany;Netherlands;Japan
226EUCTR2012-002354-23-ES
(EUCTR)
05/06/201316/01/2014A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Lilly S.A.NULLNot Recruiting Female: yes
Male: yes
134 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Poland;Belgium;Romania;Netherlands;Germany;Japan
227NCT01908699
(ClinicalTrials.gov)
May 31, 201316/7/2013Beraprost-314d Added-on to Tyvaso® (BEAT)A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology PBCNULLCompleted18 Years80 YearsAll273Phase 3United States;Israel
228EUCTR2012-002354-23-AT
(EUCTR)
23/05/201301/03/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
229EUCTR2012-000098-21-IT
(EUCTR)
22/05/201311/01/2013An Open Label Extension Study of UT-15C in subjects with PulmonaryArterial HypertensionAn Open Label Extension Study of UT-15C in subjects with PulmonaryArterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
UNITED THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858United States;Taiwan;Austria;Israel;Italy;United Kingdom;Mexico;Canada;Brazil;Australia;Germany;Netherlands;Korea, Republic of
230EUCTR2012-000097-26-IT
(EUCTR)
22/05/201319/12/2012International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostin
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
231EUCTR2012-003335-33-ES
(EUCTR)
12/05/201309/04/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Bulgaria;Germany;Israel;Italy;Vietnam;India;France;Malaysia;South Africa
232NCT03236818
(ClinicalTrials.gov)
May 201318/3/2013Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNULLActive, not recruiting18 Years80 YearsAll30Phase 4Netherlands
233EUCTR2012-002354-23-IT
(EUCTR)
12/04/201327/02/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
234NCT01795950
(ClinicalTrials.gov)
April 201312/2/2013Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAHPulmonary Arterial HypertensionDrug: PLX-PADUnited TherapeuticsNULLTerminated18 Years75 YearsBoth6Phase 1Australia
235EUCTR2012-003335-33-BG
(EUCTR)
13/03/201314/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
236EUCTR2011-002018-35-IT
(EUCTR)
08/03/201330/10/2012SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study - SPHERIC-1 OPEN EXTENSION Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1
MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
INN or Proposed INN: SILDENAFIL CITRATEASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERINULLNot RecruitingFemale: yes
Male: yes
Italy
237EUCTR2012-000098-21-NL
(EUCTR)
05/03/201310/08/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Germany;Netherlands;China;Sweden;Korea, Republic of
238EUCTR2012-003335-33-PT
(EUCTR)
01/03/201306/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
239EUCTR2012-003335-33-DE
(EUCTR)
28/02/201331/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
240EUCTR2012-003335-33-GB
(EUCTR)
27/02/201321/11/2012 Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
241EUCTR2012-003335-33-AT
(EUCTR)
19/02/201307/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
242EUCTR2012-000097-26-NL
(EUCTR)
18/02/201329/08/2012International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of;Sweden
243EUCTR2012-003335-33-BE
(EUCTR)
07/02/201323/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 16.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Israel;Chile;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
244EUCTR2012-004411-31-IT
(EUCTR)
01/02/201311/01/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient to be used for treatment of Eisenmenger Syndrome.Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome. - MAESTRO-OL Eisenmenger Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: Macitentan
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Austria;Russian Federation;Chile;Israel;Italy;Vietnam;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Romania;Bulgaria;South Africa;Germany;China
245EUCTR2012-003335-33-IT
(EUCTR)
01/02/201311/01/2013Study to evaluate if macitentan is efficient, safe and tolerable to be used for treatment of Eisenmenger Syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO Eisenmenger Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;India;Vietnam;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Bulgaria;Germany
246NCT01586156
(ClinicalTrials.gov)
December 201223/4/2012PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart FailurePulmonary HypertensionDrug: Carvedilol;Drug: placeboThe Cleveland ClinicNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Completed18 Years65 YearsAll30N/AUnited States
247EUCTR2012-000098-21-DE
(EUCTR)
14/11/201201/08/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
248EUCTR2012-000098-21-GB
(EUCTR)
06/11/201201/08/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostin
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
850 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
249EUCTR2012-000097-26-GB
(EUCTR)
06/11/201201/08/2012International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
850 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
250EUCTR2012-000098-21-AT
(EUCTR)
18/10/201207/09/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
251EUCTR2012-000097-26-AT
(EUCTR)
21/09/201207/08/2012International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
252EUCTR2012-000097-26-DE
(EUCTR)
17/09/201202/08/2012International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
850 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
253NCT01712997
(ClinicalTrials.gov)
September 201222/10/2012Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension PatientsPhase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Iloprost;Drug: BosentanFourth Military Medical UniversityNULLRecruiting10 Years80 YearsBoth90Phase 3China
254NCT01649739
(ClinicalTrials.gov)
September 201222/7/2012Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled IloprostPulmonary Arterial HypertensionDrug: LevitraRabin Medical CenterNULLNot yet recruiting18 Years70 YearsBoth20Phase 4Israel
255NCT01723371
(ClinicalTrials.gov)
September 201231/10/2012Beta Blockers for Treatment of Pulmonary Arterial Hypertension in ChildrenBeta Blockers for Treatment of Pulmonary Arterial Hypertension in ChildrenPulmonary Arterial HypertensionDrug: CarvedilolThe Hospital for Sick ChildrenNULLWithdrawn8 Years17 YearsBoth0Phase 1/Phase 2Canada
256EUCTR2012-001675-37-AT
(EUCTR)
07/08/201214/06/2012A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial HypertensionA Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Lisuride
INN or Proposed INN: Lisuride
Sinoxa Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
12Austria;Germany
257EUCTR2012-001675-37-DE
(EUCTR)
24/07/201216/05/2012A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial HypertensionA Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Lisuride
INN or Proposed INN: Lisuride
Sinoxa Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
12Austria;Germany
258EUCTR2011-004612-31-PT
(EUCTR)
06/07/201202/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
259NCT01615627
(ClinicalTrials.gov)
July 1, 20126/6/2012Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainHypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil SolutionJewish General HospitalNULLWithdrawn18 YearsN/AAll0Phase 4Canada
260NCT01560624
(ClinicalTrials.gov)
June 26, 20129/3/2012Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral MonotherapyA Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral MonotherapyPulmonary Arterial HypertensionDrug: Treprostinil Diolamine;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll690Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
261NCT01557647
(ClinicalTrials.gov)
June 201214/3/2012Safety and Efficacy of Inhaled Treprostinil in Patients With PAHInhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.Pulmonary Arterial HypertensionDrug: Inhaled treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years75 YearsBoth0Phase 3NULL
262NCT01557660
(ClinicalTrials.gov)
June 201214/3/2012Inhaled Treprostinil for PAH: Open-label ExtensionInhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center StudyPulmonary Arterial HypertensionDrug: inhaled treprostinilUnited TherapeuticsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
263NCT01560637
(ClinicalTrials.gov)
May 20129/3/2012An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionOpen-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310Pulmonary Arterial HypertensionDrug: UT-15C (treprostinil diethanolamine)United TherapeuticsNULLCompleted18 Years75 YearsAll471Phase 3United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom
264NCT01588405
(ClinicalTrials.gov)
April 20126/1/2012Remodulin® to Oral Treprostinil TransitionA Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: UT-15C SRUnited TherapeuticsNULLCompleted15 Years80 YearsAll33Phase 2United States
265EUCTR2011-004631-31-DE
(EUCTR)
13/03/201210/02/201216 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin®A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM, UT-15
United Therapeutics Corp.NULLNot RecruitingFemale: yes
Male: yes
50Germany
266NCT01433328
(ClinicalTrials.gov)
January 20129/9/2011Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainLidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: Lidocaine;Drug: PlaceboJewish General HospitalNULLTerminated18 Years85 YearsAll4Phase 4Canada
267EUCTR2011-002943-92-NL
(EUCTR)
07/11/201122/08/2011Study of a new thermostable formulation of Flolan™ to treat Pulmonary Arterial Hypertension (PAH)A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN™ in Subjects with Pulmonary Arterial Hypertension (PAH) pulmonary arterial hypertension (PAH)
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: FLOLAN™ and Glycine Diluent
Product Name: FLOLAN™ and Glycine Diluent
Product Code: 4AU76
INN or Proposed INN: EPOPROSTENOL
Trade Name: FLOLAN TM and Glycine Diluent
Product Name: FLOLAN™ and Glycine Diluent
Product Code: 4AU76
INN or Proposed INN: EPOPROSTENOL
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
20United States;Canada;Netherlands
268NCT01462565
(ClinicalTrials.gov)
November 1, 201113/10/2011Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)Hypertension, PulmonaryDrug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodiumGlaxoSmithKlineNULLCompleted18 Years75 YearsAll16Phase 4United States;Canada;Netherlands
269NCT01458236
(ClinicalTrials.gov)
November 201129/9/2011A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 InhibitorA Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 InhibitorPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology Inc.NULLWithdrawn18 Years80 YearsBoth0Phase 3NULL
270NCT01431326
(ClinicalTrials.gov)
November 201117/8/2011Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of CarePharmacokinetics of Understudied Drugs Administered to Children Per Standard of CareAdenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;InsomniaDrug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLCCompletedN/A21 YearsAll3520United States;Canada;Israel;Singapore;United Kingdom;Australia
271NCT01468545
(ClinicalTrials.gov)
October 20117/11/2011Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT SystemProspective, Non-interventional, Multi-centre Study. The Observation Period for Each Subject Covers 1 Year of Treatment. One Initial Visit and 4 Follow-up Visits Every 3 Months and One Extra Educational Reinforcement at Baseline and at 6 Months Will be Given to a Group of Patients.Pulmonary Arterial HypertensionOther: Iloprost (Ventavis inhaled, BAYQ6256)BayerDra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)Completed18 YearsN/ABoth38N/ASpain
272EUCTR2010-021572-29-IT
(EUCTR)
19/09/201107/02/2011An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064908
MedDRA version: 9.1;Classification code 10064910
MedDRA version: 9.1;Classification code 10064909
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
INN or Proposed INN: Ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
273NCT01582438
(ClinicalTrials.gov)
August 17, 201119/4/2012An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In IndiaPulmonary Arterial HypertensionDrug: Access program - sildenafil citrate, Viagra, RevatioPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLNo longer available12 Years30 YearsAllIndia
274EUCTR2010-018863-40-ES
(EUCTR)
29/07/201120/06/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Poland;Spain;Austria;Germany;United Kingdom;Italy
275EUCTR2010-021572-29-NL
(EUCTR)
19/07/201111/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
276NCT01365585
(ClinicalTrials.gov)
July 20111/6/2011Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll227Germany;Ireland
277NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)Systemic Sclerosis-Associated PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
278EUCTR2011-001312-59-GB
(EUCTR)
24/06/201115/04/2011A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial HypertensionA double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death.
MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Qutenza
Product Name: Qutenza
INN or Proposed INN: Capsaicin
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
0United Kingdom
279EUCTR2010-018863-40-GB
(EUCTR)
24/06/201124/03/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Spain;Poland;Austria;Germany;Italy;United Kingdom
280NCT01342952
(ClinicalTrials.gov)
June 21, 201126/4/2011Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is DesiredHypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLActive, not recruiting8 Years18 YearsAll66Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands
281NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
282NCT01319045
(ClinicalTrials.gov)
June 201118/3/2011Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart DiseasePulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's SyndromeDrug: IloprostUniversity of California, Los AngelesActelionTerminated18 YearsN/AAll5N/AUnited States
283NCT01392495
(ClinicalTrials.gov)
June 201111/7/2011Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLTerminatedN/AN/AAll17Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey
284NCT01352026
(ClinicalTrials.gov)
May 201110/5/2011Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: MetforminNantes University HospitalNULLWithdrawn18 Years80 YearsBoth0Phase 2France
285EUCTR2010-021793-12-ES
(EUCTR)
28/04/201103/03/2011Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonarEstudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar Hipertensión arterial pulmonar (PAH) en niños.
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
286NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension ParticipantsA Non-Randomized, Multiple Dose, Three Treatment Period, Open-Label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: Imatinib;Drug: Sildenafil;Drug: BosentanNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
287EUCTR2010-021960-14-DE
(EUCTR)
08/04/201103/03/2011An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertensionAn open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
20Germany;Italy
288EUCTR2010-021960-14-IT
(EUCTR)
11/03/201126/05/2011An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - NDAn open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
20Germany;Italy
289NCT01302444
(ClinicalTrials.gov)
March 201116/2/2011Treprostinil Combined With Tadalafil for Pulmonary HypertensionRandomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil;Drug: PlaceboRhode Island HospitalUnited TherapeuticsTerminated18 Years80 YearsAll1Phase 4United States
290EUCTR2009-014992-31-NL
(EUCTR)
16/02/201118/02/2011Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Austria;United Kingdom;United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
291EUCTR2009-014490-41-NL
(EUCTR)
16/02/201118/02/2011Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Peru;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
292EUCTR2009-014992-31-SK
(EUCTR)
09/02/201109/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
293EUCTR2010-021344-17-IT
(EUCTR)
28/01/201107/02/2011A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - NDA non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: REVATIO
INN or Proposed INN: Sildenafil
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
24Italy
294EUCTR2010-018863-40-PL
(EUCTR)
25/01/201107/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
295EUCTR2010-021572-29-ES
(EUCTR)
19/01/201117/11/2010Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired.Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired. Hipertensión Arterial PulmonarPulmonary Arterial Hypertension
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
MedDRA version: 13;Level: PT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline, S.ANULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
296EUCTR2010-021572-29-DE
(EUCTR)
11/01/201110/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
297EUCTR2010-021572-29-HU
(EUCTR)
10/01/201122/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
298EUCTR2010-018863-40-AT
(EUCTR)
05/01/201120/07/2010An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUSAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer Health Care AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Czech Republic;Germany;Spain;Italy;Poland;Austria
299NCT01332331
(ClinicalTrials.gov)
January 4, 201124/3/2011Efficacy and Safety of Ambrisentan in Children 8-18yrsA Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 YearsHypertension, PulmonaryDrug: Ambrisentan - low dose;Drug: Ambrisentan - high doseGlaxoSmithKlineNULLTerminated8 Years18 YearsAll41Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands
300JPRN-UMIN000004369
2011/01/0101/01/2011Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease Connective Tissue DiseaseBosentanTokushima UniversityNULLComplete: follow-up complete18years-old85years-oldMale and Female20Not selectedJapan
301NCT01288651
(ClinicalTrials.gov)
January 20111/2/2011Iron Deficiency In Pulmonary HypertensionIntravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial HypertensionDrug: FerricarboxymaltoseVU University Medical CenterVifor PharmaRecruiting18 YearsN/ABoth30Phase 4Netherlands
302NCT01028651
(ClinicalTrials.gov)
January 20118/12/2009A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionAn Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionPortopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: TreprostinilUnited TherapeuticsUniversity of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory UniversityCompletedN/AN/AAll13N/AUnited States
303EUCTR2010-021825-11-ES
(EUCTR)
22/12/201012/11/2010Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 Hpertensión arterial pulmonar (PAH) en niños
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
304EUCTR2010-023233-30-NL
(EUCTR)
13/12/201006/10/2010‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.Study design: Intervention studyStudy population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiencyIntervention:Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks.
MedDRA version: 12.1;Level: LLT;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Ferinject
Product Name: Ferric carboxymaltose
Product Code: RVG 33865
VU university medical centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Netherlands
305NCT01266265
(ClinicalTrials.gov)
December 201022/12/2010Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesA Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation SolutionPulmonary Arterial HypertensionDrug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitorsUnited TherapeuticsNULLCompletedN/AN/AAll1333N/AUnited States
306EUCTR2010-019547-19-IT
(EUCTR)
30/11/201014/12/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
MedDRA version: 9.1;Classification code 10065150
MedDRA version: 9.1;Classification code 10065151
MedDRA version: 9.1;Classification code 10065152
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Product Name: AMBRISENTAN
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66France;Hungary;Greece;Spain;Germany;Netherlands;Italy
307EUCTR2010-021572-29-GR
(EUCTR)
23/11/201026/10/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
308EUCTR2009-014992-31-IE
(EUCTR)
16/11/201015/04/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
1150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
309EUCTR2009-011150-17-BE
(EUCTR)
15/11/201014/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
310EUCTR2009-014490-41-IE
(EUCTR)
15/11/201014/04/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
311EUCTR2010-019547-19-FR
(EUCTR)
12/11/201023/08/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
312EUCTR2010-019547-19-NL
(EUCTR)
05/11/201001/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
313EUCTR2009-018167-26-FR
(EUCTR)
04/11/201013/09/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
314NCT01260454
(ClinicalTrials.gov)
November 20109/12/2010The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site PainThe Qutenza® Patch for Disabling Treprostinil Infusion Site PainPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: Qutenza (8% capsaicin)University of RochesterUnited TherapeuticsCompleted15 Years80 YearsAll6Phase 2United States
315EUCTR2009-014992-31-PL
(EUCTR)
19/10/201020/05/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
316EUCTR2010-019547-19-HU
(EUCTR)
15/10/201012/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
317EUCTR2010-019547-19-ES
(EUCTR)
06/10/201015/07/2010 Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Hipertensión arterial pulmonar
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
318EUCTR2010-019547-19-DE
(EUCTR)
05/10/201014/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Netherlands;Germany;Italy
319EUCTR2007-003975-38-AT
(EUCTR)
03/10/201028/08/2007Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHProof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension
Product Name: Terguride 0.5 mg tablet
INN or Proposed INN: Terguride
Other descriptive name: Transdihydrolisuride
Ergonex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
99Phase 2Czech Republic;Germany;Netherlands;Austria
320JPRN-UMIN000012669
2010/10/0101/10/2015Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- pulmonary hypertensionSildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days.Osaka Medical CollegeNULLComplete: follow-up completeNot applicable24months-oldMale and Female20Not applicableJapan
321EUCTR2009-018167-26-IT
(EUCTR)
20/09/201014/07/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension: IMPRES Extension - NDAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension: IMPRES Extension - ND pulmonary arterial hypertension
MedDRA version: 9.1;Level: PT;Classification code 10037400
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;United Kingdom;Italy
322EUCTR2009-018167-26-GB
(EUCTR)
07/09/201021/06/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Austria;Germany;Italy;United Kingdom
323NCT01094067
(ClinicalTrials.gov)
September 1, 201025/3/2010Tezosentan in Patients With Pulmonary Arterial HypertensionMulti-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.Pulmonary Arterial HypertensionDrug: ACT-050089;Other: PlaceboIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll2Phase 2United States;France;Japan
324EUCTR2009-018167-26-BE
(EUCTR)
31/08/201018/05/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 3France;Spain;Belgium;Austria;Germany;Italy;United Kingdom
325EUCTR2009-014992-31-DE
(EUCTR)
24/08/201008/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
326EUCTR2009-014490-41-DE
(EUCTR)
24/08/201010/06/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
327EUCTR2009-014992-31-CZ
(EUCTR)
20/08/201019/08/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
328EUCTR2009-011150-17-DE
(EUCTR)
16/08/201003/08/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
329EUCTR2009-011150-17-GB
(EUCTR)
11/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
330EUCTR2009-014490-41-IT
(EUCTR)
06/08/201028/12/2011Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3Belarus;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Singapore;Germany;Sweden
331EUCTR2009-014992-31-IT
(EUCTR)
06/08/201028/12/2011Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-OL Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
670Phase 3Belarus;United States;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Germany;Sweden
332NCT01355380
(ClinicalTrials.gov)
August 5, 201017/5/2011Efficacy of Ventavis Used in Real-life Setting.The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.Pulmonary Arterial HypertensionDrug: Inhaled iloprost (Ventavis, BAYQ6256)BayerNULLCompleted18 YearsN/AAll55N/APoland
333EUCTR2009-011150-17-AT
(EUCTR)
03/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
334NCT01179334
(ClinicalTrials.gov)
August 201010/8/2010Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: SildenafilBayerNULLCompleted18 Years75 YearsAll18Phase 2United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom
335NCT01077297
(ClinicalTrials.gov)
August 201025/2/2010Tezosentan in Pulmonary Arterial HypertensionMulticenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or ProstacyclinesPulmonary Arterial HypertensionDrug: TezosentanIdorsia Pharmaceuticals Ltd.NULLTerminated18 YearsN/AAll3Phase 2United States;France;Switzerland
336NCT01172496
(ClinicalTrials.gov)
August 201028/7/2010A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy VolunteersA Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy VolunteersPulmonary Arterial HypertensionDrug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth24Phase 1United States
337NCT01268553
(ClinicalTrials.gov)
August 201029/12/2010Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin MedicationTransition From Parenteral Prostanoids to Inhaled TreprostinilPulmonary Arterial HypertensionDrug: TreprostinilLos Angeles Biomedical Research InstituteUnited TherapeuticsCompleted18 Years80 YearsAll6Phase 4United States
338EUCTR2009-014992-31-AT
(EUCTR)
28/07/201028/05/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
339EUCTR2009-014490-41-AT
(EUCTR)
28/07/201028/05/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
340EUCTR2009-014490-41-HU
(EUCTR)
27/07/201018/05/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
341EUCTR2009-014992-31-HU
(EUCTR)
27/07/201001/06/2010Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
342EUCTR2010-018863-40-CZ
(EUCTR)
22/07/201002/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
343EUCTR2010-018863-40-IT
(EUCTR)
20/07/201020/08/2010An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUSAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension.
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Product Name: Riociguat
Product Name: Riociguat
Product Name: Riociguat
Product Name: Riociguat
Bayer Health Care AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
344EUCTR2010-018863-40-DE
(EUCTR)
16/07/201026/04/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
18Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
345EUCTR2010-019547-19-GR
(EUCTR)
16/07/201030/06/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
346EUCTR2009-011150-17-SE
(EUCTR)
14/07/201018/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
347EUCTR2006-000804-18-PT
(EUCTR)
02/07/201025/01/2010An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3France;Portugal;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
348NCT01153386
(ClinicalTrials.gov)
July 201028/6/2010Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil DiethanolamineAn Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth36Phase 1United States
349NCT01305252
(ClinicalTrials.gov)
July 20102/11/2010A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on TadalafilHypertension, PulmonaryDrug: treprostinil inhalations;Drug: tadalafilStanford UniversityNorthwestern UniversityCompleted18 Years69 YearsAll21Phase 4United States
350NCT01165476
(ClinicalTrials.gov)
July 201015/7/2010Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent FacilitiesAn Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth64Phase 1United States
351EUCTR2010-020917-97-IT
(EUCTR)
23/06/201028/12/2011SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1 Moderate to severe pulmonary hypertension associated to moderate to mild COPD.
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
INN or Proposed INN: SildenafilASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERINULLNot RecruitingFemale: yes
Male: yes
Italy
352EUCTR2009-018167-26-DE
(EUCTR)
04/05/201011/03/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
353NCT01105117
(ClinicalTrials.gov)
May 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll2Phase 4United States
354NCT01131845
(ClinicalTrials.gov)
May 201010/5/2010The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilAn Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.Pulmonary Arterial Hypertension;Renal DysfunctionDrug: UT-15C SR (treprostinil diethanolamine)United TherapeuticsNULLCompleted18 Years79 YearsBoth16Phase 1United States
355EUCTR2009-018167-26-AT
(EUCTR)
15/04/201016/02/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
356NCT01117987
(ClinicalTrials.gov)
April 20103/5/2010Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES ExtensionPulmonary Arterial HypertensionDrug: Imatinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll144Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden
357EUCTR2009-014490-41-GB
(EUCTR)
23/03/201017/03/2010Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
358EUCTR2009-009366-13-PT
(EUCTR)
05/03/201003/11/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
359NCT01083524
(ClinicalTrials.gov)
March 20108/3/2010Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial HypertensionA Phase I, Open-Label, Two Centre Study to Evaluate Dichloroacetate(DCA) in Advanced Pulmonary Arterial Hypertension.Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated)Drug: Dichloroacetate SodiumUniversity of AlbertaImperial College LondonCompleted18 YearsN/ABoth30Phase 1Canada;United Kingdom
360NCT01105091
(ClinicalTrials.gov)
March 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial HypertensionA Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll30Phase 4United States
361EUCTR2009-014490-41-BE
(EUCTR)
22/02/201023/11/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
362EUCTR2009-014992-31-BE
(EUCTR)
22/02/201023/11/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
363EUCTR2009-014490-41-CZ
(EUCTR)
19/02/201019/02/2010Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
364EUCTR2009-014490-41-SE
(EUCTR)
06/02/201014/12/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of
365EUCTR2009-014992-31-SE
(EUCTR)
06/02/201014/12/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
366EUCTR2009-014992-31-DK
(EUCTR)
05/02/201017/12/2009Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden;China;Netherlands;Peru;Denmark;Australia;Malaysia;France;India;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Ireland;Ukraine;Spain;Thailand;Greece;Slovakia;Taiwan;Belarus;Serbia;United States
367EUCTR2006-000804-18-SE
(EUCTR)
28/01/201003/12/2009An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
368EUCTR2009-012057-38-NL
(EUCTR)
05/01/201023/11/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
369NCT01148836
(ClinicalTrials.gov)
January 201019/3/2010Coenzyme Q-10 and Pulmonary Arterial HypertensionCoenzyme Q-10 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjectsThe Cleveland ClinicNULLCompleted18 Years55 YearsAll18N/AUnited States
370EUCTR2009-009366-13-SE
(EUCTR)
17/12/200922/10/2009A study to assess how safe and effective an oral UT-15C tablet is when given to subjects with high blood pressure in the artery that carries blood to the lungsA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;Netherlands;France;Italy;Austria;Sweden;Israel;United Kingdom;Mexico;Belgium;Puerto Rico;Spain
371EUCTR2009-014490-41-DK
(EUCTR)
08/12/200923/11/2009Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
372EUCTR2009-009366-13-FR
(EUCTR)
26/11/200906/11/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
373EUCTR2009-009366-13-ES
(EUCTR)
18/11/200924/09/2009Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Hipertensión Arterial PulmonarPulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil dietanolamina
Product Code: UT-15C SR
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
Product Name: treprostinil dietanolamina
Product Code: UT-15C
INN or Proposed INN: treprostinil dietanolamina
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Portugal;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
374EUCTR2009-009366-13-IT
(EUCTR)
17/11/200911/12/2009A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom CA 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
UNITED THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
375EUCTR2009-012057-38-IT
(EUCTR)
06/11/200930/10/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study (IMPRES) - NDA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study (IMPRES) - ND Pulmonary arterial hypertension,
MedDRA version: 9.1;Level: PT;Classification code 10037400
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
376EUCTR2009-009366-13-NL
(EUCTR)
04/11/200918/08/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
377EUCTR2009-009366-13-BE
(EUCTR)
23/10/200904/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300France;Portugal;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
378EUCTR2009-009366-13-AT
(EUCTR)
22/10/200923/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
379EUCTR2009-012450-20-FR
(EUCTR)
15/10/200907/09/2009Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclinesMulticenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines Pulmonary arterial hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Tezosentan
Product Code: ACT-050089 (Ro 61-0612)
INN or Proposed INN: tezosentan
Other descriptive name: Tezosentan
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
13Phase 2France
380EUCTR2009-012057-38-FR
(EUCTR)
21/09/200907/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
200France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
381EUCTR2009-012057-38-BE
(EUCTR)
18/09/200922/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
382EUCTR2009-009366-13-GB
(EUCTR)
02/09/200907/08/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
383NCT00963027
(ClinicalTrials.gov)
September 200919/8/2009Effect of Esomeprazole on the Pharmacokinetics of Oral TreprostinilAn Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Drug: EsomeprazoleUnited TherapeuticsNULLCompleted18 Years55 YearsBoth30Phase 1United States
384NCT00902174
(ClinicalTrials.gov)
September 200913/5/2009Imatinib (QTI571) in Pulmonary Arterial HypertensionA 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)Pulmonary Arterial HypertensionDrug: imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll202Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
385NCT00963001
(ClinicalTrials.gov)
September 200919/8/2009Effect of Food on the Pharmacokinetics of Oral TreprostinilEffect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Other: Standardized mealsUnited TherapeuticsNULLCompleted18 Years55 YearsBoth32Phase 1United States
386EUCTR2009-012057-38-GB
(EUCTR)
18/08/200915/07/2010A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
387EUCTR2009-012057-38-DE
(EUCTR)
13/08/200910/06/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec® 100 mg Filmtabletten
Product Code: QTI571
INN or Proposed INN: Imatinib mesilate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
388EUCTR2009-012057-38-SE
(EUCTR)
12/08/200908/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
389EUCTR2009-012057-38-AT
(EUCTR)
17/07/200915/06/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
390NCT00887978
(ClinicalTrials.gov)
June 200923/4/2009Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: UT-15C SR;Drug: PlaceboUnited TherapeuticsNULLCompleted18 Years75 YearsAll310Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway
391EUCTR2007-003975-38-CZ
(EUCTR)
19/05/200913/02/2009Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHProof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension
Product Name: Terguride 0.5 mg tablet
INN or Proposed INN: Terguride
Other descriptive name: Transdihydrolisuride
Ergonex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
84Phase 2Germany;Czech Republic;Netherlands;Austria
392EUCTR2007-003328-39-AT
(EUCTR)
02/04/200918/01/2008A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: NS-304
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Nippon Shinyaku Co., LTDNULLNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
393NCT00853112
(ClinicalTrials.gov)
April 200927/2/2009A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial HypertensionA Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: PF-00489791;Drug: placebo;Drug: sildenafilPfizerNULLTerminated18 YearsN/AAll48Phase 2United States;Canada;Germany;India;Russian Federation;Spain;Sweden;Switzerland;Belgium
394EUCTR2007-006453-12-AT
(EUCTR)
19/03/200923/06/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
395JPRN-UMIN000001709
2009/02/0116/02/2009Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension pulmonary arterial hypertensionadministration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor)Medical Education Center, School of Medicine, Keio UniversityNULLPending20years-oldNot applicableMale and Female10Not selectedJapan
396EUCTR2006-006748-76-BG
(EUCTR)
30/01/200906/01/2009A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
397JPRN-UMIN000001578
2008/12/0116/12/2008Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertension pulmonary arterial hypertensionadministration of tyrosine kinase inhibitor (imatinib)Medical Education CenterNULL20years-oldNot applicableMale and Female10Not selectedJapan
398NCT00760916
(ClinicalTrials.gov)
December 200825/9/2008FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary HypertensionPulmonary HypertensionDrug: UT-15C 1 mg;Drug: UT-15C 0.25 mg;Drug: UT-15C 5 mg;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years70 YearsBoth0Phase 3United States;Australia;Mexico
399EUCTR2007-003328-39-GB
(EUCTR)
05/11/200819/03/2008A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Germany;United Kingdom;Belgium;France;Italy;Austria
400EUCTR2006-001464-23-GR
(EUCTR)
04/11/200830/01/2009A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/AA multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
401EUCTR2006-006748-76-LV
(EUCTR)
22/10/200810/06/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
402EUCTR2006-006748-76-GB
(EUCTR)
15/10/200802/09/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot Recruiting Female: yes
Male: yes
219 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom
403EUCTR2007-006453-12-BE
(EUCTR)
03/10/200807/07/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02) pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
404NCT00866983
(ClinicalTrials.gov)
October 200820/3/2009Local Open-Label Access Study For Patients Who Completed A1481244 Study In BrazilA Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.Pulmonary Arterial HypertensionDrug: sildenafil (Revatio) 20 mg TIDPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLNo longer available18 YearsN/AAllBrazil
405EUCTR2007-006453-12-DE
(EUCTR)
12/09/200819/12/2008Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensionA multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: Selexipag, ACT-293987 (NS-304)
INN or Proposed INN: Selexipag
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
406NCT00741819
(ClinicalTrials.gov)
September 200823/8/2008Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsAn Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.Pulmonary Arterial HypertensionDrug: Inhaled treprostinilUnited TherapeuticsNULLCompleted18 Years75 YearsAll73Phase 4United States
407EUCTR2007-006453-12-FR
(EUCTR)
20/08/200830/06/2008A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
Product Code: NS-304
INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide
Nippon Shinyaku Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
408NCT00705588
(ClinicalTrials.gov)
August 200825/6/2008Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.Pulmonary Arterial HypertensionDrug: Tadalafil;Drug: VardenafilRabin Medical CenterNULLNot yet recruiting18 YearsN/ABoth30Phase 4Israel
409EUCTR2007-006453-12-GB
(EUCTR)
31/07/200815/07/2008A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02) pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide
Actelion Pharmaceuticals LtdNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
410EUCTR2007-006453-12-IT
(EUCTR)
15/07/200821/07/2008A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND Pulmonary Arterial Hypertension (PHA) (idiopatic PAH, familiar PHA, and associated with collagen disease, corrected congenital vitium or anorexigen)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Code: NS-304NIPPON SHINYAKU CO., LTD.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2France;Hungary;Belgium;Austria;Germany;United Kingdom;Italy
411NCT00723554
(ClinicalTrials.gov)
July 200824/7/2008Iloprost Power Disc-15 in Pulmonary Arterial HypertensionA Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®Pulmonary Arterial HypertensionDrug: Iloprost PD-6;Drug: Iloprost PD-15ActelionNULLTerminated18 Years85 YearsAll63Phase 3United States
412NCT00705133
(ClinicalTrials.gov)
July 200823/6/2008Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial HypertensionUsing Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung DiseasePulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: TreprostinilRajan SaggarUnited TherapeuticsCompletedN/AN/AAll15Phase 2United States
413NCT00718952
(ClinicalTrials.gov)
July 200818/7/2008The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial HypertensionMulti-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in ChinaPulmonary HypertensionDrug: Vardenafil;Drug: PlaceboTongji UniversityNULLCompleted12 Years65 YearsBoth60Phase 3China
414EUCTR2006-006748-76-GR
(EUCTR)
24/06/200814/03/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH).
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
415EUCTR2006-006748-76-BE
(EUCTR)
10/06/200829/01/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)INN or Proposed INN: Sildenafil citrate
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Denmark;Belgium;Bulgaria;Italy;Greece;Latvia
416EUCTR2007-003328-39-HU
(EUCTR)
25/04/200818/01/2008A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
417EUCTR2007-003328-39-BE
(EUCTR)
25/04/200827/11/2007A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
418EUCTR2006-006748-76-NL
(EUCTR)
23/04/200801/11/2007A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH).
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
419EUCTR2006-006748-76-IT
(EUCTR)
21/04/200821/02/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - NDA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - ND Pulmonary arterial hypertension (PAH).
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Trade Name: Revatio
INN or Proposed INN: Sildenafil
PFIZERNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
420EUCTR2007-003328-39-IT
(EUCTR)
11/04/200802/07/2008A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over. - NDA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over. - ND pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: NS-304
Product Code: NS-304
INN or Proposed INN: : 2-{4-[(5,6-difenilpirazin-2-yl)(isopropil)amino]butoxi}-N-
NIPPON SHINYAKU CO., LTD.NULLNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
421EUCTR2006-000804-18-DE
(EUCTR)
10/04/200812/12/2007An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Germany;Netherlands;Sweden
422NCT00430716
(ClinicalTrials.gov)
April 8, 200831/1/2007To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLTerminated18 YearsN/AAll130Phase 4United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama
423EUCTR2006-000800-17-DE
(EUCTR)
02/04/200819/05/2008A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
424EUCTR2005-005068-97-SK
(EUCTR)
06/03/200806/07/2010A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its ownEffects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
425NCT00643604
(ClinicalTrials.gov)
March 200820/3/2008Rapid Switch From Flolan to Remodulin in the Outpatient ClinicRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNULLTerminated18 Years70 YearsAll7Phase 4United States
426EUCTR2007-003975-38-NL
(EUCTR)
18/02/200817/10/2007Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHProof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension
Product Name: Terguride 0,5mg tablet
INN or Proposed INN: Terguride
Other descriptive name: Transdihydrolisuride
Ergonex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
84Phase 2Czech Republic;Germany;Netherlands;Austria
427EUCTR2007-003328-39-DE
(EUCTR)
13/02/200807/12/2007A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
428NCT00554619
(ClinicalTrials.gov)
February 20085/11/2007A Study to Evaluate GSK1325760A - a Long-Term Extension StudyStudy AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -Pulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompletedN/AN/AAll21Phase 3Japan
429EUCTR2007-003328-39-FR
(EUCTR)
23/01/200829/11/2007A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and overA multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Code: NS-304
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide
Nippon Shinyaku Co., LTDNULLNot RecruitingFemale: yes
Male: yes
44Phase 2France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
430EUCTR2006-006748-76-DK
(EUCTR)
21/01/200809/01/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
219Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;United Kingdom;Italy
431EUCTR2007-002774-64-DE
(EUCTR)
04/12/200720/08/2007Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - SildenafilTherapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. This Patients suffer from cyanosis and reduced quality of life. While EP has been regarded as not amenable to conventional treatments, new oral drugs as Sildenafil have been used successfully to improve primary arterial hypertension. Thus may be an important treatment option for patients with EP, too.Trade Name: Revatio
INN or Proposed INN: SILDENAFIL
Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene HerzfehlerNULLNot RecruitingFemale: yes
Male: yes
80Germany
432NCT00586794
(ClinicalTrials.gov)
December 200721/12/2007Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsTherapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsPulmonary Arterial Hypertension (PAH)Drug: Sildenafil;Drug: PlaceboCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and ResearchTerminated14 YearsN/ABoth24Phase 3Germany
433EUCTR2007-003975-38-DE
(EUCTR)
22/11/200728/08/2007Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAHProof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension
Product Name: Terguride 0,5mg tablet
INN or Proposed INN: Terguride
Other descriptive name: Transdihydrolisuride
Ergonex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
99Phase 2Czech Republic;Austria;Netherlands;Germany
434NCT00625469
(ClinicalTrials.gov)
October 200719/2/2008Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionWithdrawnN/AN/AAll0Phase 4United States
435EUCTR2006-000800-17-IT
(EUCTR)
27/08/200710/05/2007A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
UNITED THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
436NCT00540436
(ClinicalTrials.gov)
August 20075/10/2007Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial HypertensionStudy AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -Hypertension, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNULLCompleted18 YearsN/AAll25Phase 2Japan
437EUCTR2006-000801-50-NL
(EUCTR)
03/07/200702/04/2007A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-MA 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
438EUCTR2006-000800-17-NL
(EUCTR)
19/06/200701/12/2006A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
439EUCTR2006-000804-18-NL
(EUCTR)
19/06/200701/12/2006An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
440EUCTR2006-000801-50-IT
(EUCTR)
12/06/200721/06/2007A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-MA 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M Pulmonary Arterial Hypertension (PAH)
MedDRA version: 6.1;Level: PT;Classification code 10037400
Product Name: treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
UNITED THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
441EUCTR2006-000804-18-FR
(EUCTR)
11/06/200719/01/2007An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
442EUCTR2006-000804-18-ES
(EUCTR)
29/05/200702/03/2010Estudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTEstudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Cortocircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) VIH.
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
450Portugal;France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
443EUCTR2006-000800-17-ES
(EUCTR)
29/05/200702/03/2010Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CEstudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
444EUCTR2006-000800-17-FR
(EUCTR)
21/05/200719/01/2007A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
445EUCTR2006-000801-50-FR
(EUCTR)
21/05/200719/01/2007A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-MA 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Belgium;Austria;Netherlands;Italy
446EUCTR2006-000804-18-GB
(EUCTR)
04/05/200722/11/2006An extension study of UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
447EUCTR2006-000804-18-BE
(EUCTR)
23/04/200725/01/2007An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
448EUCTR2006-000801-50-BE
(EUCTR)
23/04/200725/01/2007A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-MA 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150France;Belgium;Austria;Netherlands;Italy
449EUCTR2006-000800-17-BE
(EUCTR)
23/04/200725/01/2007A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
450EUCTR2005-000963-25-SK
(EUCTR)
20/04/200720/03/2007A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 8.1;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
185Phase 3Slovakia;Finland;United Kingdom;Sweden
451EUCTR2005-000963-25-FI
(EUCTR)
28/03/200709/01/2007A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 8.1;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
185Finland;United Kingdom;Sweden
452EUCTR2006-002235-25-FI
(EUCTR)
28/03/200709/01/2007A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot RecruitingFemale: yes
Male: yes
204Finland;United Kingdom
453EUCTR2006-002235-25-SK
(EUCTR)
22/03/200713/02/2007A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Slovakia;Finland;United Kingdom
454NCT00458042
(ClinicalTrials.gov)
March 20075/4/2007Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment SatisfactionTransitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNULLTerminated18 Years65 YearsBoth10Phase 4United States
455EUCTR2006-000801-50-AT
(EUCTR)
19/02/200717/01/2007A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-MA 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
456EUCTR2006-000804-18-AT
(EUCTR)
19/02/200717/01/2007An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
457EUCTR2006-000800-17-IE
(EUCTR)
15/02/200713/11/2006A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
458EUCTR2006-000804-18-IE
(EUCTR)
15/02/200709/11/2006An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
459EUCTR2004-003236-59-ES
(EUCTR)
14/02/200705/05/2010Investigación clínica doble ciego controlada con placebo sobre la efficacia y la tolerabilidad de Treprostinil sódico inhaldo en pacientes con Hipertensión Pulmonar Graves.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - Hipertensión Arterial Pulmonar Grave de clase III y IV de la NYHANYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Germany;United Kingdom;Ireland;Spain;Italy
460NCT00625079
(ClinicalTrials.gov)
February 200719/2/2008Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerWithdrawnN/AN/AAll0Phase 4United States
461NCT00439946
(ClinicalTrials.gov)
February 200722/2/2007Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment SatisfactionPulmonary Arterial HypertensionDrug: treprostinil;Device: Crono Five ambulatory pumpUnited TherapeuticsNULLTerminated18 Years65 YearsAll8Phase 4United States
462EUCTR2006-000800-17-AT
(EUCTR)
19/01/200717/01/2007A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
463EUCTR2006-000800-17-GB
(EUCTR)
18/01/200722/11/2006A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-CA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprosinil Diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: Treprostinil diethanolamine
Product Name: Treprosinil Diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
464JPRN-C000000340
2007/01/0101/03/2006Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension Pulmonary arterial hypertensionTreatment with sildenafil 25mg three times daily for 24 weeks
Treatment with prior therapy without sildenafil for 24 weeks
Division of cardiovascular internal medicine, The University of Tokyo HospitalNULLComplete: follow-up complete18years-old80years-oldMale and Female20Phase 2,3Japan
465EUCTR2006-002235-25-GB
(EUCTR)
14/12/200618/09/2006A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovakia;Finland;United Kingdom
466EUCTR2006-001464-23-IT
(EUCTR)
03/11/200619/02/2007A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - NDA MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND Pulmonary Arterial Hypertension PAH .
MedDRA version: 6.1;Level: PT;Classification code 10037400
Trade Name: G04BE03- Sildenafil - sildenafil (citrato)
Product Name: Sildenafil
INN or Proposed INN: Sildenafil
PFIZERNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;United Kingdom;Italy
467EUCTR2006-001464-23-GB
(EUCTR)
18/10/200611/06/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/AA multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 8.0;Level: LLT;Classification code 10064911
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer LtdNULLNot Recruiting Female: yes
Male: yes
106 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesCzech Republic;Greece;Germany;Italy;United Kingdom
468EUCTR2004-000745-37-GB
(EUCTR)
10/10/200623/02/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Spain;Italy;United Kingdom
469NCT00325403
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: PlaceboUnited TherapeuticsNULLCompleted12 Years75 YearsAll349Phase 3United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico
470NCT00325442
(ClinicalTrials.gov)
October 200611/5/2006FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) sustained release tablets;Drug: PlaceboUnited TherapeuticsNULLCompleted12 Years70 YearsAll354Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
471EUCTR2005-000963-25-GB
(EUCTR)
13/09/200619/09/2006A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 8.1;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Finland;United Kingdom;Sweden
472NCT00373360
(ClinicalTrials.gov)
September 20067/9/2006Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to RemodulinRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionPulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNULLCompleted18 Years70 YearsAll10Phase 4United States
473NCT00323297
(ClinicalTrials.gov)
September 20065/5/2006Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)Pulmonary Arterial HypertensionDrug: Bosentan;Other: Placebo;Drug: Sildenafil CitratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czechia;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium;Czech Republic
474NCT00323024
(ClinicalTrials.gov)
September 20065/5/2006Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial HypertensionAn Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: NX1011NITROX, LLCNULLWithdrawn18 Years75 YearsBoth72Phase 2United States
475EUCTR2005-005569-12-AT
(EUCTR)
11/08/200613/07/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionProduct Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
Austria;Germany;United Kingdom
476EUCTR2006-001464-23-DE
(EUCTR)
04/07/200605/05/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension.A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Other descriptive name: n/a
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
106France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom
477NCT01062282
(ClinicalTrials.gov)
July 200620/8/2009Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Iloprost (Ventavis BAYQ6256)BayerNULLCompleted18 YearsN/ABoth41N/AKorea, Republic of
478EUCTR2005-005066-37-DE
(EUCTR)
09/06/200606/11/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United Kingdom;Germany;Italy
479EUCTR2006-001464-23-CZ
(EUCTR)
08/06/200621/04/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/AA multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
480EUCTR2005-005569-12-DE
(EUCTR)
24/05/200627/03/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionTrade Name: Glivec 100 mg Hartkapsel
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Trade Name: Glivec 100 mg Filmtabletten
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Austria;Germany;United Kingdom
481NCT00469027
(ClinicalTrials.gov)
May 20062/5/2007Pulmonary Hypertension: Assessment of Cell TherapyPhase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional TreatmentHypertension, PulmonaryBiological: eNOS transfected EPCs will be delivered via a PA lineNorthern TherapeuticsSt. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital;St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General HospitalCompleted18 Years80 YearsBoth7Phase 1Canada
482NCT01027949
(ClinicalTrials.gov)
May 20064/12/2009An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionAn Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLActive, not recruiting12 YearsN/AAll900Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
483EUCTR2005-005066-37-BE
(EUCTR)
21/04/200615/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
484EUCTR2005-002692-33-GB
(EUCTR)
10/04/200612/09/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
485EUCTR2005-002844-24-GB
(EUCTR)
10/04/200612/09/2005A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
486NCT00477269
(ClinicalTrials.gov)
April 200622/5/2007Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial HypertensionA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll59Phase 2/Phase 3United States;Austria;Germany;United Kingdom
487EUCTR2005-002844-24-ES
(EUCTR)
22/03/200612/12/2005- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Ireland;Spain;Italy
488EUCTR2005-005066-37-IT
(EUCTR)
21/03/200605/06/2006Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 Patients suffering from pulmonary arterial hypertension PAH
MedDRA version: 6.1;Level: PT;Classification code 10037400
INN or Proposed INN: SildenafilActelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Germany;United Kingdom;Italy
489EUCTR2005-005066-37-GB
(EUCTR)
15/03/200613/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Germany;Italy;United Kingdom
490NCT00303004
(ClinicalTrials.gov)
March 200614/3/2006Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeCombination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeEisenmenger SyndromeDrug: Bosentan and SildenafilRigshospitalet, DenmarkNULLCompleted18 YearsN/ABoth20Phase 3Denmark
491EUCTR2005-002844-24-IE
(EUCTR)
23/02/200612/10/2005A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Spain;Ireland;Italy
492EUCTR2005-002692-33-IE
(EUCTR)
23/02/200612/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Germany;Italy;United Kingdom
493EUCTR2005-002692-33-DE
(EUCTR)
17/02/200621/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Tadalafil
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Spain;Ireland;Germany;Italy;United Kingdom
494EUCTR2005-002692-33-IT
(EUCTR)
16/02/200623/06/2006A randomized, Double blind, Placebo controlled phase 3 Study of the phosphodiesterae Type 5 PDE Inhibiotr Tadalafil in the Treatment of patients with Pulomanry Arterial Hypertension.A randomized, Double blind, Placebo controlled phase 3 Study of the phosphodiesterae Type 5 PDE Inhibiotr Tadalafil in the Treatment of patients with Pulomanry Arterial Hypertension. Pulmonary Arterial Hypertension
MedDRA version: 6.1;Level: PT;Classification code 10037405
INN or Proposed INN: TadalafilELI LILLYNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Germany;United Kingdom;Spain;Ireland;Italy
495EUCTR2005-002844-24-IT
(EUCTR)
07/02/200612/09/2007A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension.A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension. Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
INN or Proposed INN: TadalafilELI LILLYNULLNot RecruitingFemale: yes
Male: yes
350Spain;Ireland;Germany;United Kingdom;Italy
496EUCTR2005-002692-33-ES
(EUCTR)
02/02/200612/12/2005Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYEstudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerteTrade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Belgium;Spain;Ireland;Germany;Italy;United Kingdom
497EUCTR2005-005569-12-GB
(EUCTR)
26/01/200602/12/2005A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionTrade Name: Glivec
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Austria;Germany;United Kingdom
498EUCTR2005-002692-33-BE
(EUCTR)
25/01/200626/10/2005A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGYA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Lilly ICOS LLCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Spain;Belgium;Ireland;Germany;Italy;United Kingdom
499EUCTR2005-002844-24-BE
(EUCTR)
25/01/200626/10/2005An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Eli Lilly and Company LimitedNULLNot RecruitingFemale: yes
Male: yes
350Phase 3;Phase 4Spain;Belgium;Ireland;Germany;Italy;United Kingdom
500EUCTR2004-004391-36-CZ
(EUCTR)
20/01/200605/01/2006A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
501EUCTR2005-002844-24-DE
(EUCTR)
17/01/200611/10/2005An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGXAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
350Spain;Ireland;Germany;Italy;United Kingdom
502NCT00549302
(ClinicalTrials.gov)
December 200523/10/2007Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the LungsAn Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: tadalafilEli Lilly and CompanyICOS CorporationCompleted12 YearsN/AAll357Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom
503EUCTR2005-001967-70-IT
(EUCTR)
20/10/200519/01/2007An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 Treatment of pulmonary arterial hypertension in children
MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Germany;United Kingdom;Italy
504EUCTR2005-001967-70-GB
(EUCTR)
13/10/200525/08/2005An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 Idiopathic or familial pulmonary arterial hypertensionTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;Italy;United Kingdom
505NCT00240656
(ClinicalTrials.gov)
October 200517/10/2005Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial HypertensionOfficial Title: Spironolactone Combined With Captopril and Carvedilol for the Treatment of Patients With Pulmonary Arterial Hypertension Associated With Congenital Heart Disease—Focus on Pulmonary Artery RemodelingHypertension, PulmonaryDrug: spironolactone captopril carvedilolHebei Medical UniversityNULLCompletedN/A80 YearsBothPhase 1China
506EUCTR2004-003236-59-IE
(EUCTR)
09/09/200506/07/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
Lung Rx Inc.NULLNot RecruitingFemale: yes
Male: yes
165Germany;United Kingdom;Spain;Ireland;Italy
507EUCTR2004-003236-59-AT
(EUCTR)
24/08/200520/07/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Austria;Germany;Italy;United Kingdom
508NCT00319020
(ClinicalTrials.gov)
August 23, 200526/4/2006Bosentan in Children With Pulmonary Arterial Hypertension Extension StudyAn Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1Pulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted2 Years11 YearsAll33Phase 3United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
509EUCTR2004-003236-59-BE
(EUCTR)
20/08/200515/12/2005Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
510NCT00125918
(ClinicalTrials.gov)
August 20051/8/2005PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial HypertensionPHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: tadalafil;Drug: placeboEli Lilly and CompanyICOS CorporationCompleted12 YearsN/ABoth406Phase 3United States;France;Italy;Japan;Belgium;Canada;Germany;Ireland;Spain;United Kingdom
511EUCTR2004-003236-59-GB
(EUCTR)
30/06/200513/06/2005 Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
512EUCTR2004-005157-63-IT
(EUCTR)
15/06/200515/02/2006An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAHAn open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH Treatment of pulmonary arterial hypertension in children.
MedDRA version: 6.1;Level: PT;Classification code 10037405
Trade Name: TRACLEER 62,5MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
35United Kingdom;Italy
513NCT03055221
(ClinicalTrials.gov)
June 10, 20059/2/2017TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Intravenous TreprostinilUnited TherapeuticsNULLCompleted16 Years75 YearsAll20Phase 4NULL
514NCT00147199
(ClinicalTrials.gov)
June 20052/9/2005Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Inhaled treprostinil;Drug: Placebo inhalation solutionUnited TherapeuticsNULLCompleted18 Years75 YearsAll235Phase 3United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom
515EUCTR2005-000963-25-SE
(EUCTR)
30/05/200506/04/2005Oral Revatio in Pediatric PAH- Long term follow on study to A1481131A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
200Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden
516EUCTR2004-003236-59-IT
(EUCTR)
30/05/200509/11/2009Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial HypertensionDouble Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension NYHA Class III and IV patients with severe Pulmonary Arterial Hypertensio
MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: TRE
INN or Proposed INN: Treprostinil Sodium Solution for Inhalation
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Germany;United Kingdom;Italy
517EUCTR2004-004391-36-HU
(EUCTR)
23/05/200523/02/2005A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
518NCT00494533
(ClinicalTrials.gov)
March 200527/6/2007Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial HypertensionTreprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Remodulin (treprostinil sodium)United TherapeuticsAsian Clinical TrialsTerminated16 Years75 YearsBoth45Phase 4India
519EUCTR2004-000745-37-ES
(EUCTR)
11/10/200407/10/2004Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 4Spain;Italy;United Kingdom
520EUCTR2004-000478-30-IT
(EUCTR)
09/09/200411/07/2007A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYA randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA
MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: TRACLEER*56CPR RIV 125MG
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden
521NCT00266162
(ClinicalTrials.gov)
August 200415/12/2005Bosentan in Treatment of Pulmonary Arterial HypertensionTherapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger SyndromeEisenmenger SyndromeDrug: Bosentan administrationCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research;ActelionCompleted18 YearsN/ABoth60Phase 4Germany
522NCT00159874
(ClinicalTrials.gov)
January 20048/9/2005A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In ChildrenA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
523NCT00483626
(ClinicalTrials.gov)
August 20036/6/2007Hemodynamic Response After Six Months of SildenafilHemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil TreatmentPulmonary Arterial HypertensionDrug: oral sildenafilUniversity of ChileNULLRecruiting16 Years75 YearsBoth27Phase 4Chile
524NCT00159913
(ClinicalTrials.gov)
August 20038/9/2005A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.Pulmonary Arterial Hypertension, ChildrenDrug: Sildenafil citrate;Drug: PlaceboPfizerNULLCompleted1 Year17 YearsAll235Phase 3United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore
525NCT00159861
(ClinicalTrials.gov)
July 20038/9/2005The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAHA Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.Pulmonary HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.PfizerCompleted16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom;Czech Republic
526NCT00082186
(ClinicalTrials.gov)
July 200330/4/2004The Effect of Tracleer® on Male FertilityTRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentanActelionNULLCompleted18 Years65 YearsMale22Phase 4United States;Australia;Brazil;Czech Republic;Hungary
527NCT00080457
(ClinicalTrials.gov)
May 20031/4/2004Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: sitaxsentan sodiumEncysive PharmaceuticalsNULLCompleted12 Years75 YearsBoth240Phase 3United States
528NCT00811018
(ClinicalTrials.gov)
March 20039/12/2008A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionA Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SitaxsentanPfizerNULLTerminated12 Years75 YearsAll1192Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom
529NCT00159887
(ClinicalTrials.gov)
December 20028/9/2005Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial HypertensionA Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.Pulmonary HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll260Phase 3United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic
530NCT00644605
(ClinicalTrials.gov)
October 200220/3/2008A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and OverHypertension, PulmonaryDrug: sildenafil;Drug: placeboPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll275Phase 3United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic
531NCT00058929
(ClinicalTrials.gov)
October 200214/4/2003A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial HypertensionA Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNULLCompleted18 Years75 YearsBoth39Phase 4United States
532NCT00105209
(ClinicalTrials.gov)
April 20029/3/2005A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial HypertensionA Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Aspirin;Drug: clopidogrelKawut, Steven, MDNational Heart, Lung, and Blood Institute (NHLBI);Columbia UniversityCompleted18 YearsN/ABoth20Phase 2United States
533NCT00034307
(ClinicalTrials.gov)
February 200224/4/2002Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial HypertensionA Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sitaxsentan sodiumICOS-Texas BiotechnologyICOS Corporation;Texas Biotechnology CorporationActive, not recruiting16 Years75 YearsBoth180Phase 2/Phase 3United States;Canada
534NCT02784808
(ClinicalTrials.gov)
January 200025/5/2016Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)Juvenile Idiopathic ArthritisDrug: Biological DMARDs;Drug: Non-Biologic DMARDsHoffmann-La RocheNULLCompletedN/A18 YearsBoth4557N/ANULL
535EUCTR2012-004411-31-PL
(EUCTR)
29/08/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3France;Malaysia;South Africa;Netherlands;China;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
536EUCTR2019-002817-21-IE
(EUCTR)
11/11/2021A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;China;Korea, Republic of;Finland;Lithuania;Turkey;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
537EUCTR2015-002238-37-Outside-EU/EEA
(EUCTR)
16/06/2015An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
Product Name: Revatio
Product Code: UK-92,480
INN or Proposed INN: Sildenafil citrate
Other descriptive name: SILDENAFIL CITRATE
Pfizer, Ltd.NULLNAFemale: yes
Male: yes
4India
538EUCTR2012-002354-23-GB
(EUCTR)
16/01/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
539EUCTR2010-021572-29-FR
(EUCTR)
11/10/2011Testing medicines to treat children with pulmonary arterial hypertension (PAH)Testing medicines to treat teens with pulmonary arterial hypertension (PAH)An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - Safety FU Study of Amb in 8-17yr olds Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan
540EUCTR2012-002354-23-PL
(EUCTR)
17/06/2013A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Brazil;Belgium;Romania;Germany;Netherlands;Japan
541EUCTR2014-003952-29-FR
(EUCTR)
04/12/2015Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer Healthcare AGNULLNAFemale: yes
Male: yes
20Phase 3France;Hungary;Belgium;Spain;Poland;Turkey;Netherlands;Germany;Japan;Italy;United Kingdom
542EUCTR2006-002235-25-Outside-EU/EEA
(EUCTR)
07/03/2012A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial HypertensionA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNAFemale: yes
Male: yes
235Brazil;Canada;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico;Peru;Russian Federation;Taiwan;United States
543EUCTR2014-003952-29-Outside-EU/EEA
(EUCTR)
07/12/2016Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD Pulmonary arterial hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Product Name: Riociguat granules 0.3% for oral application
Product Code: BAY63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNAFemale: yes
Male: yes
20Phase 3Turkey;Japan
544EUCTR2005-000963-25-Outside-EU/EEA
(EUCTR)
07/03/2012Oral Revatio in Pediatric PAH - Long-term follow-on Study to A1481131.A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNAFemale: yes
Male: yes
220Russian Federation;Taiwan;United States;Brazil;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico
545EUCTR2019-002817-21-FR
(EUCTR)
14/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNA Female: yes
Male: yes
237 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
546EUCTR2009-009366-13-DE
(EUCTR)
23/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
547EUCTR2019-002817-21-BE
(EUCTR)
02/12/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
548EUCTR2019-002817-21-SE
(EUCTR)
29/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
549EUCTR2011-004612-31-FR
(EUCTR)
27/08/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
550EUCTR2011-004612-31-NL
(EUCTR)
07/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
551EUCTR2019-002817-21-PL
(EUCTR)
15/10/2019A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
237Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Viet Nam;Australia;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Bulgaria;Germany;Sweden
552EUCTR2004-003236-59-DE
(EUCTR)
16/05/2006Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
220Spain;Ireland;Germany;Italy;United Kingdom
553EUCTR2005-001967-70-DE
(EUCTR)
30/08/2005An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 Idiopathic or familial pulmonary arterial hypertensionProduct Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
30United Kingdom;Germany;Italy
554EUCTR2010-019547-19-Outside-EU/EEA
(EUCTR)
16/03/2012Testing medicines to treat children with pulmonary arterial hypertension(PAH)A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
GlaxoSmithKline Research & Development LimitedNULLNAFemale: yes
Male: yes
66Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico