NCT01830517已完成4 期
Comparison of the Effects of Amlodipine and Losartan on Blood Pressure and Diurnal Variation in Hypertensive Stroke Patients
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 24-hour ambulatory mean SBP
研究概览
简要总结
This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 35 to 85 years
- •hypertensive patients who had an ischemic stroke
排除标准
- •patients aged below 35 years or above 86 years;
- •patients who had a hemorrhagic stroke;
- •patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit;
- •patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions
- •patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics;
- •(7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT ≥ 100); (10) patients with severely impaired renal function (serum creatinine ≥ 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs
研究组 & 干预措施
amlodipine camsylate
Experimental
amlodipine camsylate 5mg
干预措施: Amlodipine, Losartan (Drug)
losartan potassium
Active Comparator
losartan potassium 50mg
干预措施: Amlodipine, Losartan (Drug)
结局指标
主要结局
24-hour ambulatory mean SBP
时间窗: baseline and 8weeks
次要结局
- 24H mean DBP, 24H mean SBP/DBP Variability,clinic SBP/DBP, awake, sleep, morning, evening, and prewake BPs, the morning surge, and the nocturnal dipping(baseline and 8weeks)
研究者
研究点 (1)
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