NCT00940680已完成3 期
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 100mg Versus Losartan 100mg in Patients With Essential Hypertension Not Controlled on Losartan Monotherapy
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2008年4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
- 142
- 试验地点
- 1
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure
研究概览
简要总结
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.
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 (Participant, Investigator)
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
- •Patients over 18 years of age
- •Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
- •Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)
排除标准
- •mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
- •mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
- •has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
- •Secondary hypertensive patient or suspected to be
- •Uncontrolled diabetes mellitus patients
- •Severe heart disease or severe neurovascular disease
- •Known as severe or malignant retinopathy
- •Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
- •History of malignancy tumor
- •History of autoimmune disease
- •History of alcohol or drug abuse
- •Positive to pregnancy test, nursing mother, has an intention on pregnancy
- •Considered by investigator as not appropriate to participate in the clinical study with othe reason
研究组 & 干预措施
amlodipine/losartan 5/100mg
Experimental
干预措施: Amlodipine plus Losartan (Drug)
losartan 100mg
Active Comparator
干预措施: Losartan (Drug)
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure
时间窗: Week 8
次要结局
- Change from baseline in mean sitting systolic blood pressure(Week 4, 8)
- Change from baseline in mean sitting diastolic blood pressure(Week 4)
- Responder rate(Week 4, 8)
研究者
研究点 (1)
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