CClinicalTrials.gg
CompletedNCT00345774Updated May 29, 2008

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

A Phase 2 interventional study of PRX-08066 in Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, sponsored by Epix Pharmaceuticals, Inc.. Completed at 19 sites in United States. Open to participants aged 25 Years to 79 Years. Per ClinicalTrials.gov, last updated 2008-05-29.

Sponsored by Epix Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
25 Years to 79 Years
Sex
All
01

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.

02

Conditions studied

  • Pulmonary Hypertension
  • Chronic Obstructive Pulmonary Disease

Keywords

  • Pulmonary Hypertension
  • PH
  • Pulmonary Arterial Hypertension
  • PAH
  • Chronic Obstructive Pulmonary Disease
  • COPD
  • PRX-08066
  • Predix
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 72 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Epix Pharmaceuticals, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
72 participants (estimated)

Interventions

  • DrugPRX-08066
06

What researchers measure

Primary outcomes

  1. Systolic Pulmonary Artery Pressure

Secondary outcomes

  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

07

Study locations

19 sites
  • Pinnacle Research Group, LLC
    Anniston, Alabama 36207, United States
  • Arizona Pulmonary Specialists, Ltd.
    Phoenix, Arizona 85013, United States
  • University of California-Davis Medical Group
    Sacramento, California 95817, United States
  • University Clinical Research-DeLand, LLC
    DeLand, Florida 32720, United States
  • Central Medical Group, PA
    Tamarac, Florida 33321, United States
  • Clinical Research of West Florida, Inc.
    Tampa, Florida 33603, United States
  • Atlanta Insitute for Medical Research
    Decatur, Georgia 30030, United States
  • Pulmonary Consultants of North Idaho
    Coeur d'Alene, Idaho 83814, United States
  • Loyola University Medical Center Foster McGraw Hospital
    Maywood, Illinois 60153, United States
  • Veritas Clinical Specialities
    Topeka, Kansas 66606, United States
  • Tufts New England Medical Center
    Boston, Massachusetts 02111, United States
  • Massachusetts General Hospital, Pulmonary Critical Care Unit
    Boston, Massachusetts 02114, United States
  • Buffalo Cardiology and Pulmonary Associates, P.C.
    Williamsville, New York 14221, United States
  • American Health Research
    Charlotte, North Carolina 28207, United States
  • South Carolina Pharmaceutical Research
    Spartanburg, South Carolina 29303, United States
  • Spartanburg Medical Research
    Spartanburg, South Carolina 29303, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Morgantown Pulmonary Clinical Research
    Morgantown, West Virginia 26505, United States
  • Heart Care Associates, LLC
    Milwaukee, Wisconsin 53215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00345774
Lead sponsor
Epix Pharmaceuticals, Inc.
First posted
Jun 28, 2006
Start date
Jun 2006
Completion
Jun 2007
Last update
May 29, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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