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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Short-Term Efficacy and Safety of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345774
• Other study ID #: PRX-CP-017
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2006
• Last updated: May 27, 2008
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: May 2008
• Source: Epix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 79 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• PRX-08066

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Epix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Pulmonary Artery Pressure
Secondary	Safety
Secondary	6 minute walk distance
Secondary	Borg Dyspnea Index
Secondary	BDI/TDI
Secondary	Echocardiograms
Secondary	Spirometry
Secondary	Oxygen saturation
Secondary	WHO functional classification