NCT00063687已完成2 期
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
Advanz Pharma4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2003年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究者
研究点 (4)
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