Status:
COMPLETED
Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Epix Pharmaceuticals, Inc.
Conditions:
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
25-79 years
Phase:
PHASE2
Brief Summary
This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
Eligibility Criteria
Inclusion
- 25 to 79 years old.
- Provide voluntary written informed consent to participate.
- Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
- Diagnosis of chronic obstructive pulmonary disease.
- Become short of breath with physical activity.
- Elevated systolic pulmonary artery pressures.
- Not pregnant, nursing, or planning a pregnancy.
Exclusion
- Left ventricular ejection fraction \<30%.
- Heart attack or stroke within the last 6 months.
- History of lung resection surgery.
- Use of supplemental oxygen \>20 hours/day.
- Blood donation or significant blood loss within the last 56 days.
- Plasma donation within the last 14 days.
- Use of any drugs for another research study within the last 30 days.
- Use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
- Positive blood screen Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
- Major surgery within the last 28 days.
- Any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00345774
Start Date
June 1 2006
End Date
June 1 2007
Last Update
May 29 2008
Active Locations (19)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85013
3
University of California-Davis Medical Group
Sacramento, California, United States, 95817
4
University Clinical Research-DeLand, LLC
DeLand, Florida, United States, 32720