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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.
 
ClinicalTrials.gov Identifier: NCT00345774
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : May 29, 2008
Sponsor:
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

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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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00345774


Locations
Show Show 19 study locations
Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
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ClinicalTrials.gov Identifier: NCT00345774    
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
PH
Pulmonary Arterial Hypertension
PAH
Chronic Obstructive Pulmonary Disease
COPD
PRX-08066
Predix
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases