86. 肺動脈性肺高血圧症
[臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185

Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
31 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000025176
2017/01/0115/12/2016Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. Pulmonary arterial hypertensionMedicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.
Hamamatsu University School of MedicineNULLOpen public recruiting16years-oldNot applicableMale and Female33Not selectedJapan
2EUCTR2016-003495-53-NL
(EUCTR)
29/11/201615/12/2016Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defectProstacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Selexipag
Product Name: Selexipag
Academic Medical Center - CardiologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
3NCT02436512
(ClinicalTrials.gov)
June 201513/4/2015Study to Assess Acute Vasodilation Response of Inhaled Nitric OxideA Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideGeno LLCNULLWithdrawn18 Years70 YearsBoth0Phase 3United States
4JPRN-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
5NCT02276872
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-142721
01/9/201427/11/2014ACT-385781A for PAH pediatric patientsProspectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : epoprostenol
Dosage And administration of the intervention : continuous intravenous infusion
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH3Phase 3NULL
7JPRN-JapicCTI-132142
01/4/201303/06/2013ACT-385781A PAH Post-marketing studyA Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : Epoprostenol
Dosage And administration of the intervention : A commercially available epoprostenol sodium preparation will be switched to the study drug at the same dose
Actelion Pharmaceuticals Japan Ltd.NULL20BOTH5Phase 4NULL
8EUCTR2010-018320-10-ES
(EUCTR)
26/12/201121/11/2011An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)Extension del estudio AC-066A301, abierta, para investigar la seguridad y la tolerabilidad de ACT-385781A en pacientes con Hipertension Arterial Pulmonar (HAP) - EPITOME-2 Extension Hipertension Arterial Pulmonar
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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Netherlands;Italy
9EUCTR2011-002943-92-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
10EUCTR2010-018320-10-IT
(EUCTR)
04/11/201101/03/2012An extension of study AC-066A301 to investigate safety and tolerabilityof the study medication (epoprostenol for injection)Estensione in aperto dello studio AC-066A301 per valutare la sicurezza e la tollerabilita' dell’ACT-385781A nei pazienti affetti da ipertensione arteriosa polmonare (IAP) - EPITOME-2 Extension 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]
Trade Name: Epoprostenolo per iniezione
INN or Proposed INN: EPOPROSTENOL SODIUM
Other descriptive name: NA
Trade Name: Epoprostenolo per iniezione
INN or Proposed INN: EPOPROSTENOL SODIUM
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Canada;Spain;Belgium;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01462565
(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
12JPRN-JapicCTI-122017
01/8/201103/12/2012ACT-385781A PAHOpen-label study ACT-385781A in patients with pulmonary arterial hypertension 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.NULL20BOTH10Phase 3NULL
13EUCTR2010-018320-10-NL
(EUCTR)
11/07/201112/05/2011An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension 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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Netherlands;Italy
14EUCTR2010-018322-40-NL
(EUCTR)
11/07/201119/07/2011A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3bNetherlands;Belgium;France;Spain;Italy
15EUCTR2010-018322-40-ES
(EUCTR)
17/06/201103/11/2011Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonarEstudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Hipertensión Arterial Pulmonar (HAP)
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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3bFrance;Canada;Belgium;Spain;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01470144
(ClinicalTrials.gov)
June 1, 201128/10/2011Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionAn Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: EpoprostenolActelionChiltern International Ltd.;Effi-statCompletedN/AN/AAll41Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
17EUCTR2010-018322-40-IT
(EUCTR)
04/05/201105/01/2012A clinical research study to evaluate the safety of changing from Flolanto a new drug called Epoprostenol-Actelion in patients suffering frompulmonary arterial hypertensionUno studio multicentrico, a braccio singolo, in aperto, di fase 3b, per valutare gli effetti del passaggio da Flolan ad ACT 385781A nei pazienti con ipertensione arteriosa polmonare - EPITOME-2 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]
Trade Name: Epoprostenolo per iniezione
INN or Proposed INN: Epoprostenol
Trade Name: Epoprostenol for injection
INN or Proposed INN: Epoprostenol
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Canada;Netherlands;Belgium;France;Spain;Italy
18NCT01431716
(ClinicalTrials.gov)
March 20117/9/2011Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNULLCompleted18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
19NCT01266265
(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
20NCT01077297
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01268553
(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
22EUCTR2010-018320-10-BE
(EUCTR)
02/07/201013/04/2010An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension 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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Spain;Belgium;Netherlands;Italy
23EUCTR2010-018322-40-BE
(EUCTR)
02/07/201007/04/2010A clinical research study to evaluate the safety of changing from Flolan to a new drug called Epoprostenol-Actelion in patients suffering from pulmonary arterial hypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Canada;Spain;Belgium;Netherlands;Italy
24EUCTR2010-018322-40-FR
(EUCTR)
20/05/201029/03/2010A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol-Actelion
Product Name: Epoprostenol-Actelion
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3bNetherlands;Belgium;France;Spain;Italy
25NCT01105117
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01105091
(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
27EUCTR2009-012450-20-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 2aFrance
28NCT00643604
(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
29NCT00439946
(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
30NCT00373360
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00159861
(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 citratePfizerNULLCompleted16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czech Republic;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom