Ventavis ( 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28

86. 肺動脈性肺高血圧症


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
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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
2NCT02826252
(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
3NCT02825160
(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
4EUCTR2014-000091-25-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
5NCT02032836
(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
6EUCTR2013-002783-12-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
7EUCTR2013-002783-12-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
8NCT01894035
(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
9NCT01781052
(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
10NCT01469169
(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
11NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
12NCT01355380
(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
13EUCTR2009-010703-80-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
14EUCTR2009-011013-24-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
15EUCTR2009-010703-80-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
16NCT00902603
(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
17NCT00741819
(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
18EUCTR2007-002803-42-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
19EUCTR2005-006192-13-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
20NCT00458042
(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
21EUCTR2005-006192-13-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
22EUCTR2005-006192-13-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
23NCT00453414
(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
24NCT01062282
(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
25EUCTR2005-006192-13-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
26EUCTR2005-006192-13-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
27EUCTR2005-006192-13-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
28NCT00302211
(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