Clinical trial NCT00345774: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Hypertension
PH
Pulmonary Arterial Hypertension
PAH
Chronic Obstructive Pulmonary Disease
COPD
PRX-08066
Predix
Lead sponsor: Epix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Systolic Pulmonary Artery Pressure
Secondary outcomes:
measure: Safety
measure: 6 minute walk distance
measure: Borg Dyspnea Index
measure: BDI/TDI
measure: Echocardiograms
measure: Spirometry
measure: Oxygen saturation
measure: WHO functional classification
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: Sacramento
country: United States
facility: University of California-Davis Medical Group
state: California
city: DeLand
country: United States
facility: University Clinical Research-DeLand, LLC
state: Florida
city: Tamarac
country: United States
facility: Central Medical Group, PA
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Decatur
country: United States
facility: Atlanta Insitute for Medical Research
state: Georgia
city: Coeur d'Alene
country: United States
facility: Pulmonary Consultants of North Idaho
state: Idaho
city: Maywood
country: United States
facility: Loyola University Medical Center Foster McGraw Hospital
state: Illinois
city: Topeka
country: United States
facility: Veritas Clinical Specialities
state: Kansas
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital, Pulmonary Critical Care Unit
state: Massachusetts
city: Williamsville
country: United States
facility: Buffalo Cardiology and Pulmonary Associates, P.C.
state: New York
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Spartanburg
country: United States
facility: South Carolina Pharmaceutical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Morgantown
country: United States
facility: Morgantown Pulmonary Clinical Research
state: West Virginia
city: Milwaukee
country: United States
facility: Heart Care Associates, LLC
state: Wisconsin
Study officials:
References: