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OpenTrials
Completed

NCT Number: NCT00345774

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Arterial Hypertension Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

25 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25 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.

Exclusion criteria

  • 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.

Treatment and study plan

PRX-08066

Drug

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

Sponsors and collaborators

Lead sponsor

Epix Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Jun 28, 2006
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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