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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00302211 |
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: Iloprost Inhalation Solution (Ventavis) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 180 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Robyn J Barst, MD | Steering Committee Advisor |
Study Chair: | David B Badesch, MD, FACP, FCCP | Steering Committee Advisor |
Responsible Party: | Actelion Pharmaceuticals US ( Actelion Pharmaceuticals US/Sponsor ) |
Study ID Numbers: | C200-006 |
Study First Received: | March 10, 2006 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00302211 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PAH Pulmonary Arterial Hypertension |
Vasodilator Agents Vascular Diseases Sildenafil Cardiovascular Agents Bosentan Iloprost Phosphodiesterase Inhibitors |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Hypertension Platelet Aggregation Inhibitors Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Enzyme Inhibitors Sildenafil Cardiovascular Agents Pharmacologic Actions Iloprost |
Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Hypertension |