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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345774
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : May 29, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Chronic Obstructive Pulmonary Disease Drug: PRX-08066 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2006
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. Systolic Pulmonary Artery Pressure

Secondary Outcome Measures :
  1. Safety
  2. 6 minute walk distance
  3. Borg Dyspnea Index
  4. BDI/TDI
  5. Echocardiograms
  6. Spirometry
  7. Oxygen saturation
  8. WHO functional classification

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345774

United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85013
United States, California
University of California-Davis Medical Group
Sacramento, California, United States, 95817
United States, Florida
University Clinical Research-DeLand, LLC
DeLand, Florida, United States, 32720
Central Medical Group, PA
Tamarac, Florida, United States, 33321
Clinical Research of West Florida, Inc.
Tampa, Florida, United States, 33603
United States, Georgia
Atlanta Insitute for Medical Research
Decatur, Georgia, United States, 30030
United States, Idaho
Pulmonary Consultants of North Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Loyola University Medical Center Foster McGraw Hospital
Maywood, Illinois, United States, 60153
United States, Kansas
Veritas Clinical Specialities
Topeka, Kansas, United States, 66606
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital, Pulmonary Critical Care Unit
Boston, Massachusetts, United States, 02114
United States, New York
Buffalo Cardiology and Pulmonary Associates, P.C.
Williamsville, New York, United States, 14221
United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
United States, South Carolina
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States, 29303
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, West Virginia
Morgantown Pulmonary Clinical Research
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Heart Care Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Epix Pharmaceuticals, Inc. Identifier: NCT00345774     History of Changes
Other Study ID Numbers: PRX-CP-017
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Epix Pharmaceuticals, Inc.:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases