Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01437878
Last Updated: 2015-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2012-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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iloprost
single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system
Iloprost
5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
placebo
matching placebo using the power disc-6 with I-neb AAD system
Placebo
matching placebo
Interventions
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Iloprost
5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
Placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 40 and ≤ 75 years of age
3. Women of childbearing potential1 must use a reliable method of contraception
4. Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
5. Current or past smokers of ≥ 10 pack years
6. Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
7. Confirmed pulmonary hypertension by right heart catheterization (RHC)
Exclusion Criteria
2. BMI \> 35 kg/m2
3. Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
4. Pregnant or nursing
5. Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
6. Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
7. Known concomitant life-threatening disease with a life expectancy \< 12 months
8. Known hypersensitivity to iloprost or any of the excipients of the drug formulations
40 Years
75 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Frederic Bodin, MD
Role: STUDY_DIRECTOR
Actelion
Locations
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Los Angeles Biomedical Research Institute
Torrance, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Hopital d'adultes de Brabois
Vandœuvre-lès-Nancy, , France
Hospital Clinic i Provincial
Barcelona, , Spain
Countries
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Other Identifiers
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AC-063B201
Identifier Type: -
Identifier Source: org_study_id