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

Last updated: May 27, 2008
Sponsor: Epix Pharmaceuticals, Inc.
Overall Status: Completed

Phase

2

Condition

Chest Pain

Diabetes And Hypertension

High Blood Pressure (Hypertension)

Treatment

N/A

Clinical Study ID

NCT00345774
PRX-CP-017
  • Ages 25-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, endothelinantagonists, 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, thevalidity of the study results, or interfere with the completion of the study accordingto the protocol.

Study Design

Total Participants: 72
Study Start date:
June 01, 2006
Estimated Completion Date:
June 30, 2007

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • University of California-Davis Medical Group

    Sacramento, California 95817
    United States

    Site Not Available

  • University Clinical Research-DeLand, LLC

    DeLand, Florida 32720
    United States

    Site Not Available

  • Central Medical Group, PA

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33603
    United States

    Site Not Available

  • Atlanta Insitute for Medical Research

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Pulmonary Consultants of North Idaho

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • Loyola University Medical Center Foster McGraw Hospital

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Veritas Clinical Specialities

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Massachusetts General Hospital, Pulmonary Critical Care Unit

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Buffalo Cardiology and Pulmonary Associates, P.C.

    Williamsville, New York 14221
    United States

    Site Not Available

  • American Health Research

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • South Carolina Pharmaceutical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Morgantown Pulmonary Clinical Research

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • Heart Care Associates, LLC

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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