Treprostin ( 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123

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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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
2EUCTR2021-004002-21-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
3NCT04791514
(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
4NCT03833323
(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
5NCT04309838
(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
6NCT03884465
(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
7NCT03950739
(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
8NCT03992755
(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
9NCT03835676
(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
10NCT04062565
(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
11JPRN-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
12EUCTR2018-003414-40-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
13EUCTR2018-003414-40-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
14NCT04041648
(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
15NCT03497689
(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
16NCT03464864
(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
17NCT03399604
(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
18NCT02999906
(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
19NCT03045029
(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
20NCT02882126
(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
21NCT03016468
(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
22NCT02893995
(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
23EUCTR2012-000098-21-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
24EUCTR2012-000097-26-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
25EUCTR2012-000098-21-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
26NCT02471183
(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
27NCT02276872
(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
28EUCTR2012-000097-26-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
29EUCTR2012-000098-21-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
30EUCTR2012-000098-21-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
31EUCTR2012-000097-26-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
32EUCTR2012-000097-26-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
33EUCTR2012-000098-21-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
34EUCTR2012-000097-26-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
35EUCTR2012-000098-21-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
36NCT01934582
(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
37NCT01908699
(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
38EUCTR2012-000097-26-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
39EUCTR2012-000098-21-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
40EUCTR2012-000098-21-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
41EUCTR2012-000097-26-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
42EUCTR2012-000098-21-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
43EUCTR2012-000098-21-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
44EUCTR2012-000097-26-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
45EUCTR2012-000098-21-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
46EUCTR2012-000097-26-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
47EUCTR2012-000097-26-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
48NCT01615627
(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
49NCT01560624
(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
50NCT01557647
(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
51NCT01557660
(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
52NCT01560637
(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
53NCT01588405
(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
54EUCTR2011-004631-31-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
55NCT01433328
(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
56EUCTR2011-001312-59-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
57NCT01302444
(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
58NCT01028651
(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
59NCT01266265
(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
60NCT01260454
(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
61NCT01172496
(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
62NCT01268553
(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
63EUCTR2006-000804-18-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
64NCT01153386
(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
65NCT01165476
(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
66NCT01305252
(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
67NCT01131845
(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
68EUCTR2009-009366-13-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
69EUCTR2006-000804-18-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
70EUCTR2009-009366-13-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
71EUCTR2009-009366-13-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
72EUCTR2009-009366-13-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
73EUCTR2009-009366-13-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
74EUCTR2009-009366-13-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
75EUCTR2009-009366-13-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
76EUCTR2009-009366-13-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
77EUCTR2009-009366-13-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
78NCT00963001
(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
79NCT00963027
(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
80NCT00760916
(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
81NCT00741819
(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
82NCT00705133
(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
83EUCTR2006-000804-18-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
84EUCTR2006-000800-17-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
85NCT00643604
(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
86EUCTR2006-000800-17-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
87EUCTR2006-000801-50-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
88EUCTR2006-000804-18-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
89EUCTR2006-000800-17-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
90EUCTR2006-000801-50-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
91EUCTR2006-000804-18-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
92EUCTR2006-000800-17-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
93EUCTR2006-000804-18-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
94EUCTR2006-000800-17-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
95EUCTR2006-000801-50-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
96EUCTR2006-000804-18-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
97EUCTR2006-000804-18-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
98EUCTR2006-000800-17-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
99EUCTR2006-000801-50-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
100NCT00458042
(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
101EUCTR2006-000804-18-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
102EUCTR2006-000801-50-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
103EUCTR2006-000800-17-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
104EUCTR2006-000804-18-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
105EUCTR2004-003236-59-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
106NCT00439946
(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
107EUCTR2006-000800-17-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
108EUCTR2006-000800-17-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
109NCT00325403
(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
110NCT00325442
(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
111NCT00373360
(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
112NCT01027949
(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
113EUCTR2004-003236-59-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
114EUCTR2004-003236-59-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
115EUCTR2004-003236-59-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
116EUCTR2004-003236-59-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
117NCT03055221
(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
118NCT00147199
(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
119EUCTR2004-003236-59-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
120NCT00494533
(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
121NCT00058929
(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
122EUCTR2004-003236-59-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
123EUCTR2009-009366-13-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