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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345774

Enrollment

Registered

2006-06-28

Start date

2006-06-30

Completion date

2007-06-30

Last updated

2008-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Keywords

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

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.

Interventions

DRUGPRX-08066

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

25 Years to 79 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Systolic Pulmonary Artery Pressure	—

Secondary

Measure	Time frame
6 minute walk distance	—
Borg Dyspnea Index	—
BDI/TDI	—
Safety	—
Spirometry	—
Oxygen saturation	—
WHO functional classification	—
Echocardiograms	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026