NCT00345774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

First QC Date

June 27, 2006

Last Update Submit

May 27, 2008

Conditions

Pulmonary HypertensionChronic Obstructive Pulmonary Disease

Keywords

Pulmonary HypertensionPHPulmonary Arterial HypertensionPAHChronic Obstructive Pulmonary DiseaseCOPDPRX-08066Predix

Outcome Measures

Primary Outcomes (1)

  • Systolic Pulmonary Artery Pressure

Secondary Outcomes (8)

  • Safety

  • 6 minute walk distance

  • Borg Dyspnea Index

  • BDI/TDI

  • Echocardiograms

  • +3 more secondary outcomes

Interventions

PRX-08066DRUG

Eligibility Criteria

Age25 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85013, United States

Location

University of California-Davis Medical Group

Sacramento, California, 95817, United States

Location

University Clinical Research-DeLand, LLC

DeLand, Florida, 32720, United States

Location

Central Medical Group, PA

Tamarac, Florida, 33321, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Atlanta Insitute for Medical Research

Decatur, Georgia, 30030, United States

Location

Pulmonary Consultants of North Idaho

Coeur d'Alene, Idaho, 83814, United States

Location

Loyola University Medical Center Foster McGraw Hospital

Maywood, Illinois, 60153, United States

Location

Veritas Clinical Specialities

Topeka, Kansas, 66606, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital, Pulmonary Critical Care Unit

Boston, Massachusetts, 02114, United States

Location

Buffalo Cardiology and Pulmonary Associates, P.C.

Williamsville, New York, 14221, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

South Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Morgantown Pulmonary Clinical Research

Morgantown, West Virginia, 26505, United States

Location

Heart Care Associates, LLC

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic ObstructivePulmonary Arterial Hypertension

Interventions

5-((4-(6-chlorothieno(2,3-d)pyrimidin-4-ylamino)piperidin-1-yl)methyl)-2-fluorobenzonitrile

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2007

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

US(19)