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

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

Study Overview

• Status: Terminated
• Conditions: Pulmonary Hypertension; COPD
• Intervention / Treatment: Drug: PRX-08066

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Pulmonary and Critical Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: PRX-08066

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Central hemodynamic and exercise capacity parameters utilizing RHC and CPET

Collaborators and Investigators

• Sponsor: Epix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 28, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Moderate to severe COPD and coincident pulmonary hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: PRX-08066-202