Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00345774
• Lead Sponsor: Epix Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Study Completion: 2007-06
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. 25 to 79 years old.
2. Provide voluntary written informed consent to participate.
3. Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
4. Diagnosis of chronic obstructive pulmonary disease.
5. Become short of breath with physical activity.
6. Elevated systolic pulmonary artery pressures.
7. Not pregnant, nursing, or planning a pregnancy.

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Exclusion Criteria

1. Left ventricular ejection fraction <30%.
2. Heart attack or stroke within the last 6 months.
3. History of lung resection surgery.
4. Use of supplemental oxygen >20 hours/day.
5. Blood donation or significant blood loss within the last 56 days.
6. Plasma donation within the last 14 days.
7. Use of any drugs for another research study within the last 30 days.
8. Use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
9. Positive blood screen Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
10. Major surgery within the last 28 days.
11. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Pulmonary Artery Pressure

Secondary Outcome Measures

Name	Time	Method
Safety
6 minute walk distance
Borg Dyspnea Index
BDI/TDI
Echocardiograms
Spirometry
Oxygen saturation
WHO functional classification

Trial Locations

Locations (19)

Pulmonary Consultants of North Idaho; 🇺🇸 Coeur d'Alene, Idaho, United States

Central Medical Group, PA; 🇺🇸 Tamarac, Florida, United States

Buffalo Cardiology and Pulmonary Associates, P.C.; 🇺🇸 Williamsville, New York, United States

American Health Research; 🇺🇸 Charlotte, North Carolina, United States

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

University Clinical Research-DeLand, LLC; 🇺🇸 DeLand, Florida, United States

Atlanta Insitute for Medical Research; 🇺🇸 Decatur, Georgia, United States

Loyola University Medical Center Foster McGraw Hospital; 🇺🇸 Maywood, Illinois, United States

Tufts New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital, Pulmonary Critical Care Unit; 🇺🇸 Boston, Massachusetts, United States

Spartanburg Medical Research; 🇺🇸 Spartanburg, South Carolina, United States

Morgantown Pulmonary Clinical Research; 🇺🇸 Morgantown, West Virginia, United States

Arizona Pulmonary Specialists, Ltd.; 🇺🇸 Phoenix, Arizona, United States

Heart Care Associates, LLC; 🇺🇸 Milwaukee, Wisconsin, United States

Veritas Clinical Specialities; 🇺🇸 Topeka, Kansas, United States

South Carolina Pharmaceutical Research; 🇺🇸 Spartanburg, South Carolina, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of California-Davis Medical Group; 🇺🇸 Sacramento, California, United States

Clinical Research of West Florida, Inc.; 🇺🇸 Tampa, Florida, United States