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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Intervention / Treatment: Drug: PRX-08066

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Arizona Pulmonary Specialists, Ltd.
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis Medical Group
  • Florida
    • DeLand, Florida, United States, 32720
      • University Clinical Research-Deland, LLC
    • Tamarac, Florida, United States, 33321
      • Central Medical Group, PA
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Atlanta Insitute for Medical Research
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Pulmonary Consultants of North Idaho
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center Foster McGraw Hospital
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Veritas Clinical Specialities
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts New England Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital, Pulmonary Critical Care Unit
  • New York
    • Williamsville, New York, United States, 14221
      • Buffalo Cardiology and Pulmonary Associates, P.C.
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
    • Spartanburg, South Carolina, United States, 29303
      • South Carolina Pharmaceutical Research
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Morgantown Pulmonary Clinical Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Heart Care Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Systolic Pulmonary Artery Pressure

Secondary Outcome Measures

Outcome Measure
Safety
Spirometry
Oxygen saturation
6 minute walk distance
Borg Dyspnea Index
BDI/TDI
Echocardiograms
WHO functional classification

Collaborators and Investigators

• Sponsor: Epix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion (ACTUAL): June 1, 2007

Study Registration Dates

• First Submitted: June 27, 2006
• First Submitted That Met QC Criteria: June 27, 2006
• First Posted (ESTIMATE): June 28, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2008
• Last Update Submitted That Met QC Criteria: May 27, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: COPD; Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease; Pulmonary Arterial Hypertension; PAH; PH; PRX-08066; Predix
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Hypertension; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary
• Other Study ID Numbers: PRX-CP-017