NCT00942344已完成2 期
An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 2 个国家目标入组 320 人开始时间: 2007年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Average changes from baseline in sitDBP
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75
- •Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}
排除标准
- •Patients with mean sitSBP ≥ 200 mmHg
- •Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
- •Patients with secondary hypertension or suspected secondary hypertension
- •Patients with malignant hypertension
- •Patients who have received any medications with possible interactions with study drugs
- •Patients with uncontrolled diabetes
- •Patients with severe heart disease or severe cerebrovascular disease
- •Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
- •Patients with a history of malignant disease
- •Patients with a history of autoimmune disease
- •Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
- •Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
结局指标
主要结局
Average changes from baseline in sitDBP
时间窗: Week 8
次要结局
- Average changes from baseline in sitDBP(Week 4)
- Average changes from baseline in sitSBP(Week 4, 8)
- Blood pressure responder rate(Week 4, 8)
研究者
研究点 (2)
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