86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

  
39 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03293407
(ClinicalTrials.gov)
February 1, 201820/9/2017Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionVentavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizerBayerNULLCompleted18 YearsN/AAll31Germany
2JPRN-UMIN000027284
2017/07/0101/07/2017The effect of iloprost on pulmonary hypertension and exercuse capacityThe effect of iloprost on pulmonary hypertension and exercuse capacity - Iloprost for Pulmonary Hypertension Pulmonary arterial hypertensioninhale of iloprostThe University of Tokushima Graduate School of Health BiosciencesNULLPending20years-old90years-oldMale and Female20Not selectedJapan
3NCT03365479
(ClinicalTrials.gov)
May 1, 201727/11/2017Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionAcute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: IloprostUniversity of GiessenNULLCompleted18 YearsN/AAll30N/AGermany
4NCT02826252
(ClinicalTrials.gov)
September 15, 20165/7/2016Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)Hypertension, PulmonaryDrug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD systemBayerNULLCompleted18 YearsN/AAll64N/AGermany
5NCT02825160
(ClinicalTrials.gov)
August 1, 201615/6/2016Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLRecruitingN/AN/AAll270Japan
6EUCTR2014-000091-25-GB
(EUCTR)
01/09/201411/07/2014A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndromeA single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome - Iloprost in patients with Eisenmenger Syndrome Pulmonary Arterial Hypertension Eisenmenger syndrome
MedDRA version: 17.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855
MedDRA version: 17.0;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Iloprost
Product Name: Ventavis
INN or Proposed INN: Iloprost
Royal Brompton and Harefield NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
15Phase 4United Kingdom
7NCT02032836
(ClinicalTrials.gov)
March 10, 20149/1/2014Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)BayerNULLCompleted18 YearsN/AAll27Phase 1/Phase 2Austria;Germany
8EUCTR2013-002783-12-DE
(EUCTR)
07/01/201418/09/2013NoA multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks
MedDRA version: 16.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ventavis 10
Product Name: Ventavis 10
Product Code: Bay Q 6256
INN or Proposed INN: ILOPROST
Trade Name: Ilomedin 20 [20 µg / ml]
Product Name: Ilomedin 20
Product Code: Bay q 6256
INN or Proposed INN: ILOPROST
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2Austria;Germany
9EUCTR2013-002783-12-AT
(EUCTR)
02/12/201318/10/2013NoA multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks
MedDRA version: 19.0;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ventavis 10
Product Name: Ventavis 10
Product Code: Bay Q 6256
INN or Proposed INN: ILOPROST
Trade Name: Ilomedin 20 [20 µg / ml]
Product Name: Ilomedin 20
Product Code: Bay q 6256
INN or Proposed INN: ILOPROST
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2Austria;Germany
10NCT01894035
(ClinicalTrials.gov)
September 23, 20133/7/2013Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for InhalationStudy to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.Pulmonary HypertensionDrug: Iloprost (Ventavis, BAYQ 6256)BayerNULLCompleted18 YearsN/AAll13Portugal
11NCT01781052
(ClinicalTrials.gov)
September 11, 201322/1/2013Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsDAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Ventavis (Iloprost, BAYQ6256)BayerNULLCompleted18 YearsN/AAll17N/AFrance
12NCT01649739
(ClinicalTrials.gov)
September 201222/7/2012Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled IloprostPulmonary Arterial HypertensionDrug: LevitraRabin Medical CenterNULLNot yet recruiting18 Years70 YearsBoth20Phase 4Israel
13NCT01712997
(ClinicalTrials.gov)
September 201222/10/2012Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension PatientsPhase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Iloprost;Drug: BosentanFourth Military Medical UniversityNULLRecruiting10 Years80 YearsBoth90Phase 3China
14NCT01469169
(ClinicalTrials.gov)
June 19, 20128/11/2011Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation StudyA Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Iloprost (Ventavis inhaled, BAYQ6256)BayerNULLCompleted18 Years75 YearsAll27Phase 3Japan
15NCT01319045
(ClinicalTrials.gov)
June 201118/3/2011Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart DiseasePulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's SyndromeDrug: IloprostUniversity of California, Los AngelesActelionTerminated18 YearsN/AAll5N/AUnited States
16NCT01054105
(ClinicalTrials.gov)
October 201021/1/2010Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial HypertensionThe Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug TherapyPulmonary Arterial HypertensionDrug: IloprostGachon University Gil Medical CenterSeoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;BayerCompleted20 Years80 YearsAll73Korea, Republic of
17NCT01355380
(ClinicalTrials.gov)
August 5, 201017/5/2011Efficacy of Ventavis Used in Real-life Setting.The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.Pulmonary Arterial HypertensionDrug: Inhaled iloprost (Ventavis, BAYQ6256)BayerNULLCompleted18 YearsN/AAll55N/APoland
18EUCTR2009-010703-80-DE
(EUCTR)
11/06/200917/04/2009A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Indication: Symptomatic Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Ventavis
Product Name: Iloprost
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
63Germany;Austria
19EUCTR2009-010703-80-AT
(EUCTR)
03/06/200904/05/2009A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Indication: Symptomatic Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Ventavis
Product Name: Iloprost
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
63Germany;Austria
20EUCTR2009-011013-24-AT
(EUCTR)
03/06/200930/04/2009A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 ExtensionA Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension Indication: Symptomatic Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Ventavis
Product Name: Iloprost
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
63Austria
21NCT00902603
(ClinicalTrials.gov)
March 200913/5/2009Ventavis® Registry ProtocolRegistry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Commercial Ventavis® (iloprost)ActelionNULLTerminated19 YearsN/ABoth148N/AUnited States
22NCT00709098
(ClinicalTrials.gov)
September 20081/7/2008Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprostActelionNULLCompleted18 YearsN/AAll49Phase 3United States;Austria;Germany
23NCT00741819
(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
24NCT00723554
(ClinicalTrials.gov)
July 200824/7/2008Iloprost Power Disc-15 in Pulmonary Arterial HypertensionA Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®Pulmonary Arterial HypertensionDrug: Iloprost PD-6;Drug: Iloprost PD-15ActelionNULLTerminated18 Years85 YearsAll63Phase 3United States
25NCT00709956
(ClinicalTrials.gov)
July 20081/7/2008Iloprost Power 15 in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: iloprost (5 µg);Drug: placeboActelionNULLCompleted18 YearsN/AAll64Phase 3United States;Austria;Germany
26EUCTR2007-002803-42-AT
(EUCTR)
05/03/200820/02/2008Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trialInhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic perfusion pressures limits the systemic use of potent vasodilators in this patient population. As a consequence, no therapeutic recommendations exist for patients experiencing right heart failure in the course of PAH.Trade Name: Ventavis(Iloprost)
Product Name: Ventavis(Iloprost)
Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, AustriaNULLNot RecruitingFemale: yes
Male: yes
8Austria
27EUCTR2005-006192-13-PT
(EUCTR)
26/04/200730/11/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISIONA randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
28NCT00458042
(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
29NCT00403650
(ClinicalTrials.gov)
November 200624/11/2006Inhaled Iloprost for Sarcoidosis-associated Pulmonary HypertensionInhaled Iloprost for Sarcoidosis Associated Pulmonary HypertensionSarcoidosis;Pulmonary Arterial HypertensionDrug: IloprostUniversity of CincinnatiNULLCompleted18 Years90 YearsBoth20Phase 4United States
30EUCTR2005-006192-13-IT
(EUCTR)
19/09/200612/04/2007A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION primary pulmonary hypertension ICD IX 416.8
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: ventavis
INN or Proposed INN: Iloprost
COTHERIX, INC.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Portugal;Spain;Austria;Germany;United Kingdom;Italy
31EUCTR2005-006192-13-DE
(EUCTR)
06/07/200603/05/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;United Kingdom;Germany;Spain;Italy;Austria
32NCT01062282
(ClinicalTrials.gov)
July 200620/8/2009Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Iloprost (Ventavis BAYQ6256)BayerNULLCompleted18 YearsN/ABoth41N/AKorea, Republic of
33NCT00453414
(ClinicalTrials.gov)
July 200627/3/2007Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial HypertensionSafety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Iloprost Inhalation Solution (Ventavis)ActelionNULLWithdrawn3 Years18 YearsBoth0Phase 2United States
34EUCTR2005-006192-13-GB
(EUCTR)
22/06/200621/03/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
35EUCTR2005-006192-13-ES
(EUCTR)
09/06/200612/05/2006Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIONEstudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Classification code 10037400
Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter.
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Portugal;Spain;Austria;Germany;Italy;United Kingdom
36EUCTR2005-006192-13-AT
(EUCTR)
15/05/200605/05/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
37NCT00302211
(ClinicalTrials.gov)
February 1, 200610/3/2006The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral SildenafilPulmonary HypertensionDrug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNULLTerminated12 Years85 YearsAll67Phase 3United States
38NCT00120380
(ClinicalTrials.gov)
September 200411/7/2005Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial HypertensionHypertensionDrug: Aerosolized iloprost;Drug: PlaceboHannover Medical SchoolNULLTerminated18 Years75 YearsBoth40Phase 4Germany
39NCT00086463
(ClinicalTrials.gov)
June 20041/7/2004Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAHPulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary HypertensionDrug: Iloprost or placeboActelionNULLCompleted12 Years75 YearsBoth60Phase 2United States