NCT01766505终止4 期
Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 9
- 主要终点
- change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
研究概览
简要总结
The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.
详细描述
This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients who aged above 19 and below 75
- •Patients with 90~109mmHg average sitting DBP on baseline
- •NYHA class 2~4
- •Patients who agreement with written informed consent
排除标准
- •above 110mmHg sitting DBP and/or 180mmHg sitting SBP
- •Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening
- •Patients who have medical history that secondary hypertension or rule out secondary hypertension
- •malignant hypertension
- •symptomatic postural hypotension
- •right heart failure due to pulmonary disease
研究组 & 干预措施
Candemore tablet
Experimental
Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks
干预措施: Candemore tablet (Drug)
Cozzar tablet
Active Comparator
Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks
干预措施: Cozzar tablet (Drug)
结局指标
主要结局
change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks
时间窗: baseline, 16 weeks
次要结局
- change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks(baseline, 8 weeks)
- change from baseline average sitting SBP(systolic blood pressure)at 8 weeks(baseline, 8 weeks)
- change from baseline average sitting SBP(systolic blood pressure)at 16 weeks(baseline, 16 weeks)
- ratio of normalize from baseline blood pressure at 16 weeks(baseline, 16 weeks)
- change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks(baseline, 16 weeks)
- change from baseline LV(left ventricular) mass at 16 weeks(baseline, 16 weeks)
- change from baseline PWV(pulse wave velocity) mass at 16 weeks(baseline, 16 weeks)
- response ratio from baseline blood pressure at 16 weeks(baseline, 16 weeks)
- change from baseline LVEF(left ventricular ejection fraction at 16 weeks(baseline, 16 weeks)
研究者
研究点 (9)
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