Status:
TERMINATED
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Actelion
Conditions:
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main obje...
Eligibility Criteria
Inclusion
- Signed informed consent prior to initiation of any study mandated procedure
- Male or female ≥ 40 and ≤ 75 years of age
- Women of childbearing potential1 must use a reliable method of contraception
- Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
- Current or past smokers of ≥ 10 pack years
- Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
- Confirmed pulmonary hypertension by right heart catheterization (RHC)
Exclusion
- Other causes of pulmonary hypertension than COPD
- BMI \> 35 kg/m2
- Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
- Pregnant or nursing
- Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
- Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
- Known concomitant life-threatening disease with a life expectancy \< 12 months
- Known hypersensitivity to iloprost or any of the excipients of the drug formulations
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01437878
Start Date
March 1 2012
End Date
November 1 2012
Last Update
November 20 2015
Active Locations (11)
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1
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70112