Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
NCT ID: NCT00345774
Last Updated: 2008-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2006-06-30
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRX-08066
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
25 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Epix Pharmaceuticals, Inc.
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRX-CP-017
Identifier Type: -
Identifier Source: org_study_id