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

Primary Purpose

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRX-08066
Sponsored by
Epix Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Hypertension, PH, Pulmonary Arterial Hypertension, PAH, Chronic Obstructive Pulmonary Disease, COPD, PRX-08066, Predix

Eligibility Criteria

25 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Arizona Pulmonary Specialists, Ltd.
  • University of California-Davis Medical Group
  • University Clinical Research-DeLand, LLC
  • Central Medical Group, PA
  • Clinical Research of West Florida, Inc.
  • Atlanta Insitute for Medical Research
  • Pulmonary Consultants of North Idaho
  • Loyola University Medical Center Foster McGraw Hospital
  • Veritas Clinical Specialities
  • Tufts New England Medical Center
  • Massachusetts General Hospital, Pulmonary Critical Care Unit
  • Buffalo Cardiology and Pulmonary Associates, P.C.
  • American Health Research
  • South Carolina Pharmaceutical Research
  • Spartanburg Medical Research
  • Baylor College of Medicine
  • Morgantown Pulmonary Clinical Research
  • Heart Care Associates, LLC

Outcomes

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

Full Information

First Posted
June 27, 2006
Last Updated
May 27, 2008
Sponsor
Epix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00345774
Brief Title
Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
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 Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Epix Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary Hypertension, PH, Pulmonary Arterial Hypertension, PAH, Chronic Obstructive Pulmonary Disease, COPD, PRX-08066, Predix

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PRX-08066
Primary Outcome Measure Information:
Title
Systolic Pulmonary Artery Pressure
Secondary Outcome Measure Information:
Title
Safety
Title
6 minute walk distance
Title
Borg Dyspnea Index
Title
BDI/TDI
Title
Echocardiograms
Title
Spirometry
Title
Oxygen saturation
Title
WHO functional classification

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California-Davis Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University Clinical Research-DeLand, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Central Medical Group, PA
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Atlanta Insitute for Medical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Pulmonary Consultants of North Idaho
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Loyola University Medical Center Foster McGraw Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Veritas Clinical Specialities
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital, Pulmonary Critical Care Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Buffalo Cardiology and Pulmonary Associates, P.C.
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
South Carolina Pharmaceutical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Morgantown Pulmonary Clinical Research
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Heart Care Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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

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