NCT01127217已完成3 期
The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Change from baseline in MSSBP
研究概览
简要总结
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.
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
- •18 aged or over
- •Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
- •Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg
排除标准
- •Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
- •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- •History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
- •Secondary hypertension or suspected to be
- •Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
- •Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
- •History of severe neurovascular disease, severe heart disease
- •Known as moderate or malignant retinopathy.
- •Renal diseases; serum creatinine ≥ 2mg/dl
- •Hepatic diseases; increase in ALT or AST ≥ 2xUNL
- •Hyponatremia/hypokalemia or hypercalcemia
- •Active Gout
- •Surgical or medical diseases which might significantly change ADME of medicines
- •History of malignant tumor
- •Autoimmune diseases
- •History of alcohol or drug abuse
- •Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
- •Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
amlodipine/losartan
Experimental
干预措施: amlodipine/losartan (Drug)
amlodipine
Active Comparator
干预措施: amlodipine (Drug)
结局指标
主要结局
Change from baseline in MSSBP
时间窗: Baseline, Week 6
次要结局
- Change from baseline in MSSBP(Baseline, Week 2 and 8)
- Change from baseline MSDBP(Baseline, Week 2, 6, and 8)
- Blood pressure responder rate(Baseline, Week 2, 6, 8)
研究者
研究点 (1)
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