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Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure

This study has been completed.

Sponsored by: Cardiome Pharma
Information provided by: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT00063687
  Purpose

The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.


Condition Intervention Phase
Congestive Heart Failure
Drug: Oxypurinol
Phase II
Phase III

MedlinePlus related topics:   Heart Failure   

Drug Information available for:   Oxypurinol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure

Further study details as provided by Cardiome Pharma:

Estimated Enrollment:   400
Study Start Date:   March 2003
Estimated Study Completion Date:   June 2005

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria

  • 18-85 years old,
  • Stable NYHA Class III-IV
  • Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen.
  • EF =< 40%

Exclusion criteria

  • Any condition (other than CHF) that could limit exercise
  • Any concurrent disease likely to limit life expectancy.
  • Participation in another clinical trial
  • Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy
  • Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063687

Locations
United States, California
Carr-Dzindzio Cardiology    
      Oceanside, California, United States, 92056
United States, Maryland
Johns Hopkins University    
      Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center    
      Boston, Massachusetts, United States, 02118
United States, New York
Saint Vincents Hospital and Medical Center    
      New York, New York, United States, 10011

Sponsors and Collaborators
Cardiome Pharma

Investigators
Principal Investigator:     Joshua Hare, MD     Johns Hopkins University    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   500-02-01
First Received:   July 2, 2003
Last Updated:   August 3, 2005
ClinicalTrials.gov Identifier:   NCT00063687
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Oxypurinol

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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