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

Completed · Phase 2

Conditions studied: Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00345774

Run by

Epix Pharmaceuticals, Inc.

People needed

72

Starts

2006-06-01

Expected to finish

2007-06-01

Last updated by the study team

2008-05-29

Who can join

Age: 25 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
• University of California-Davis Medical Group — Sacramento, California, United States
• University Clinical Research-DeLand, LLC — DeLand, Florida, United States
• Central Medical Group, PA — Tamarac, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Atlanta Insitute for Medical Research — Decatur, Georgia, United States
• Pulmonary Consultants of North Idaho — Coeur d'Alene, Idaho, United States
• Loyola University Medical Center Foster McGraw Hospital — Maywood, Illinois, United States
• Veritas Clinical Specialities — Topeka, Kansas, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital, Pulmonary Critical Care Unit — Boston, Massachusetts, United States
• Buffalo Cardiology and Pulmonary Associates, P.C. — Williamsville, New York, United States
• American Health Research — Charlotte, North Carolina, United States
• South Carolina Pharmaceutical Research — Spartanburg, South Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• Morgantown Pulmonary Clinical Research — Morgantown, West Virginia, United States
• Heart Care Associates, LLC — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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