86. Pulmonary arterial hypertension Clinical trials / Disease details
Clinical trials : 1,181 / Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03293407 (ClinicalTrials.gov) | February 1, 2018 | 20/9/2017 | Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizer | Bayer | NULL | Completed | 18 Years | N/A | All | 31 | Germany | |
| 2 | NCT02826252 (ClinicalTrials.gov) | September 15, 2016 | 5/7/2016 | 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) | 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, Pulmonary | Drug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD system | Bayer | NULL | Completed | 18 Years | N/A | All | 64 | N/A | Germany |
| 3 | NCT02825160 (ClinicalTrials.gov) | August 1, 2016 | 15/6/2016 | Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | NULL | Recruiting | N/A | N/A | All | 270 | Japan | |
| 4 | EUCTR2014-000091-25-GB (EUCTR) | 01/09/2014 | 11/07/2014 | A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome | A 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | United Kingdom | ||
| 5 | NCT02032836 (ClinicalTrials.gov) | March 10, 2014 | 9/1/2014 | Comparative 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 Hypertension | Pulmonary Arterial Hypertension | Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL) | Bayer | NULL | Completed | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | Austria;Germany |
| 6 | EUCTR2013-002783-12-DE (EUCTR) | 07/01/2014 | 18/09/2013 | No | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1;Phase 2 | Austria;Germany | ||
| 7 | EUCTR2013-002783-12-AT (EUCTR) | 02/12/2013 | 18/10/2013 | No | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1;Phase 2 | Austria;Germany | ||
| 8 | NCT01894035 (ClinicalTrials.gov) | September 23, 2013 | 3/7/2013 | Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation | Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost. | Pulmonary Hypertension | Drug: Iloprost (Ventavis, BAYQ 6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 13 | Portugal | |
| 9 | NCT01781052 (ClinicalTrials.gov) | September 11, 2013 | 22/1/2013 | Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 17 | N/A | France |
| 10 | NCT01469169 (ClinicalTrials.gov) | June 19, 2012 | 8/11/2011 | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study | A 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, Pulmonary | Drug: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 3 | Japan |
| 11 | NCT01468545 (ClinicalTrials.gov) | October 2011 | 7/11/2011 | Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System | Prospective, Non-interventional, Multi-centre Study. The Observation Period for Each Subject Covers 1 Year of Treatment. One Initial Visit and 4 Follow-up Visits Every 3 Months and One Extra Educational Reinforcement at Baseline and at 6 Months Will be Given to a Group of Patients. | Pulmonary Arterial Hypertension | Other: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain) | Completed | 18 Years | N/A | Both | 38 | N/A | Spain |
| 12 | NCT01389206 (ClinicalTrials.gov) | June 1, 2011 | 6/7/2011 | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi | Actelion | Canadian Heart Research Centre | Completed | 18 Years | N/A | All | 797 | United States;Puerto Rico | |
| 13 | NCT01355380 (ClinicalTrials.gov) | August 5, 2010 | 17/5/2011 | Efficacy of Ventavis Used in Real-life Setting. | The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme. | Pulmonary Arterial Hypertension | Drug: Inhaled iloprost (Ventavis, BAYQ6256) | Bayer | NULL | Completed | 18 Years | N/A | All | 55 | N/A | Poland |
| 14 | EUCTR2009-010703-80-DE (EUCTR) | 11/06/2009 | 17/04/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 63 | Germany;Austria | ||||
| 15 | EUCTR2009-011013-24-AT (EUCTR) | 03/06/2009 | 30/04/2009 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 63 | Austria | |||
| 16 | EUCTR2009-010703-80-AT (EUCTR) | 03/06/2009 | 04/05/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 63 | Germany;Austria | ||||
| 17 | NCT00902603 (ClinicalTrials.gov) | March 2009 | 13/5/2009 | Ventavis® Registry Protocol | Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Commercial Ventavis® (iloprost) | Actelion | NULL | Terminated | 19 Years | N/A | Both | 148 | N/A | United States |
| 18 | NCT00741819 (ClinicalTrials.gov) | September 2008 | 23/8/2008 | Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects | An 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 Hypertension | Drug: Inhaled treprostinil | United Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 73 | Phase 4 | United States |
| 19 | EUCTR2007-002803-42-AT (EUCTR) | 05/03/2008 | 20/02/2008 | Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial | Inhaled 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, Austria | NULL | Not Recruiting | Female: yes Male: yes | 8 | Austria | |||
| 20 | EUCTR2005-006192-13-PT (EUCTR) | 26/04/2007 | 30/11/2006 | 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 (PAH) 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 (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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 21 | NCT00458042 (ClinicalTrials.gov) | March 2007 | 5/4/2007 | Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction | Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | Both | 10 | Phase 4 | United States |
| 22 | EUCTR2005-006192-13-IT (EUCTR) | 19/09/2006 | 12/04/2007 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Austria;Germany;United Kingdom;Italy | ||
| 23 | EUCTR2005-006192-13-DE (EUCTR) | 06/07/2006 | 03/05/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;United Kingdom;Germany;Spain;Italy;Austria | |||
| 24 | NCT01062282 (ClinicalTrials.gov) | July 2006 | 20/8/2009 | Hypertension 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 Hypertension | Pulmonary Hypertension | Drug: Iloprost (Ventavis BAYQ6256) | Bayer | NULL | Completed | 18 Years | N/A | Both | 41 | N/A | Korea, Republic of |
| 25 | NCT00453414 (ClinicalTrials.gov) | July 2006 | 27/3/2007 | Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension | Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Iloprost Inhalation Solution (Ventavis) | Actelion | NULL | Withdrawn | 3 Years | 18 Years | Both | 0 | Phase 2 | United States |
| 26 | EUCTR2005-006192-13-GB (EUCTR) | 22/06/2006 | 21/03/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 27 | EUCTR2005-006192-13-ES (EUCTR) | 09/06/2006 | 12/05/2006 | Estudio 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 | Estudio 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Austria;Germany;Italy;United Kingdom | ||
| 28 | EUCTR2005-006192-13-AT (EUCTR) | 15/05/2006 | 05/05/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
| 29 | NCT00302211 (ClinicalTrials.gov) | February 1, 2006 | 10/3/2006 | The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension | 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 | Pulmonary Hypertension | Drug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | 85 Years | All | 67 | Phase 3 | United States |