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

Sponsor
Advanz Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00063687
Collaborator
(none)
400
Enrollment
4
Locations
27
Duration (Months)
100
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Mar 1, 2003
Study Completion Date :
Jun 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Carr-Dzindzio Cardiology Oceanside California United States 92056
    2 Johns Hopkins University Baltimore Maryland United States 21287
    3 Boston Medical Center Boston Massachusetts United States 02118
    4 Saint Vincents Hospital and Medical Center New York New York United States 10011

    Sponsors and Collaborators

    • Advanz Pharma

    Investigators

    • Principal Investigator: Joshua Hare, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00063687
    Other Study ID Numbers:
    • 500-02-01
    First Posted:
    Jul 3, 2003
    Last Update Posted:
    Aug 5, 2005
    Last Verified:
    Jul 1, 2003
    Additional relevant MeSH terms:
    Heart Failure
    Oxypurinol

    Study Results

    No Results Posted as of Aug 5, 2005