NCT00294086已完成2 期
A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class Ll-lll)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure
研究概览
简要总结
This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 years or older
- •Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1
- •Patients must remain on their prior standard care CHF therapy
排除标准
- •Diagnosis of severe hypertension (SBP>180 and DBP>110 mm Hg)
- •Right heart failure due to pulmonary disease
- •Presence of rapidly deteriorating heart failure
- •MI or cardiac surgery, including PTCA within 3 months of Visit 1
- •Unstable angina or coronary artery disease likely to require CABG or PTCA
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure
次要结局
- Patients reaching target dose at 10 weeks
- Change from baseline in systolic blood pressure at each study visit
- Change from baseline in diastolic blood pressure at each study visit
- Change from baseline in blood potassium at each study visit
- Change from baseline in blood creatinine at each study visit
研究者
研究点 (2)
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