NCT00272805已完成3 期
Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction
Cardiovascular Clinical Sciences Inc104 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 104
- 主要终点
- Dosing compliance: pill taking total taken vs number prescribed
研究概览
简要总结
The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.
详细描述
Study Further Study Details:
Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)
Expected Total Enrollment: 400 subjects at 56 study sites in the U.S.
Study Start: October 2005
This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to read English
- •Stable symptoms of mild to severe heart failure
- •Stable medical regimen for heart failure
- •On a stable dose of Coreg for at least 2 months
- •LVEF ≤40% within the previous 24 months
排除标准
- •Uncorrected obstructive or regurgitant valve disease
- •Complex congenital heart disease
- •Recent ICD or pacemaker placement
- •Recent coronary artery bypass surgery or stroke
- •Candidate for heart transplanct within 5 months of study start
- •Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
结局指标
主要结局
Dosing compliance: pill taking total taken vs number prescribed
次要结局
- quality of life
研究者
研究点 (104)
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