An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

This study has been terminated.
Sponsor:
Information provided by:
Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00677872
First received: May 13, 2008
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with pulmonary hypertension and COPD.


Condition Intervention Phase
COPD
Pulmonary Hypertension
Drug: PRX-08066
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Epix Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Six-minute walk test (6-MWT)and mean pulmonary artery pressure (MPAP) utilizing right heart catheterization.

Secondary Outcome Measures:
  • Central hemodynamic and exercise capacity parameters utilizing RHC and CPET

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRX-08066

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and Women >40 years of age
  • Diagnosis of COPD with an FEV1 above 20% and less than 65% of predicted normal and an FEV1-to-FVC ratio of less than 70%
  • Diagnosis of pulmonary hypertension based on echocardiography within the last 6 months or by cardiac catheterization within the last 12 months
  • New York Heart Association(NYHA)Class II or III
  • Screening LVEF>55%, obtained by any appropriate method within 6 months of screening
  • Baseline 6MWT distance>150m and <450m
  • Written informed consent from each subject prior to the initiation of any study-related procedure
  • Documented negative results (within 12 months)and Hepatitis B and Hepatitis C Serology

Exclusion Criteria:

  • Treatment for pulmonary hypertension with epoprostenol (prostacyclin), trepostinil (Remodulin), iloprost (Ventavis), bosentan (Tracleer), ambrisentan (Letairis), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) within the 30 days prior to study entry
  • Presence or history of any of the following cardiovascular co-morbidities or conditions: Un-controlled systemic hypertension at screening; unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening; amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the 3 months prior to screening; significant valvular heart disease; cerebrovascular accident or transient ischemic attack within 3 months prior to screening
  • COPD exacerbation less than 1 month prior to screening
  • Exercise tolerance limited by non-cardiac causes
  • Clinically significant psychiatric, addictive, neurologic disease or condition
  • Chronic renal impairment or renal insufficiency
  • No clinically significant laboratory abnormalities
  • Subjects currently being treated for PH with prostnoids, PDE-5 inhibitors and or endothelin receptor antagonist. The use of PDE-5 inhibitors "as needed" for erectile dysfunction is acceptable as long as the subject does not take the medication within 72 hours of an efficacy assessment. Other concomitant medications are allowed provided the subject has been on a stable dose regimen for at least 4 weeks prior to enrollment and the regimen continues and remains stable during the treatment and follow-up periods.
  • History of nasal airway mass, septal perforation, chronic sinusitis, lidocaine allergy or current nasal passage condition that would decrease the safety or tolerability of a naso-esophageal catheter
  • The subject has the presence, or history, of malignancy that required significant medical intervention within the preceding 3 months and/or is likely to result in death within the next 2 years
  • The receipt of any investigational medication within 30 days prior to screening or anytime during the course of the study
  • Women cannot be pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677872

Locations
United States, Massachusetts
Massachusetts General Hospital Pulmonary and Critical Care Unit
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Elkan Gamzu, PhD, EPIX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00677872     History of Changes
Other Study ID Numbers: PRX-08066-202
Study First Received: May 13, 2008
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Epix Pharmaceuticals, Inc.:
Moderate to severe COPD and coincident pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014