Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)



Status:Terminated
Conditions:Chronic Obstructive Pulmonary Disease, High Blood Pressure (Hypertension), Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 75
Updated:4/21/2016
Start Date:March 2012
End Date:November 2012

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A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease

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 objective is to investigate the effect of iloprost on exercise endurance
time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety
endpoints will additionally be analyzed.


Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure

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:

1. Other causes of pulmonary hypertension than COPD

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
We found this trial at
10
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Jacksonville, Florida 32216
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Jacksonville, FL
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New Orleans, Louisiana 70121
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New Orleans, LA
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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Torrance, California 90502
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Torrance, CA
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Vandoeuvre-lès-Nancy, 54500
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Vandoeuvre-lès-Nancy,
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