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

This study has been completed.
Sponsor:
Information provided by:
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT00063687
First received: July 2, 2003
Last updated: August 3, 2005
Last verified: July 2003
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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: 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

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on July 20, 2014