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

Sponsored by:	Epix Pharmaceuticals, Inc.
Information provided by:	Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00345774

Purpose

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	Intervention	Phase
Pulmonary Hypertension Chronic Obstructive Pulmonary Disease	Drug: PRX-08066	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) High Blood Pressure Pulmonary Hypertension

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Epix Pharmaceuticals, Inc.:

Primary Outcome Measures:

Systolic Pulmonary Artery Pressure

Secondary Outcome Measures:

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

Estimated Enrollment:	72
Study Start Date:	June 2006
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	25 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345774

Locations

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
Central Medical Group, PA
Tamarac, Florida, United States, 33321
University Clinical Research-DeLand, LLC
DeLand, Florida, United States, 32720
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
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
South Carolina Pharmaceutical 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.

More Information

Study ID Numbers:	PRX-CP-017
Study First Received:	June 27, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00345774
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epix Pharmaceuticals, Inc.:

Pulmonary Hypertension
PH
Pulmonary Arterial Hypertension
PAH

Chronic Obstructive Pulmonary Disease
COPD
PRX-08066
Predix

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Lung Diseases, Obstructive
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Respiration Disorders
Vascular Diseases
Hypertension
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009