NCT02058446已完成4 期
An Open-label, Postmarketing Study of Amlodipine/Valsartan Single-Pill Combination for the Treatment of Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.
研究概览
简要总结
The antihypertensive effect of Amlodipine/Valsartan combination has been evaluated in worldwide populations including Asian patients. The study primarily aims to evaluate the effectiveness of Amlodipine/Valsartan combination in patients with essential hypertension in Taiwan using a prospective, open-label, non-randomized approach.
The study also wants to investigate the safety of Amlodipine/Valsartan combination during the 6-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 20-80 years of age
- •Patients with essential hypertension (90 mmHg ≤ DBP ≤ 110 mmHg and/or 140 mmHg ≤ SBP ≤ 180 mmHg) whose BP is not adequately controlled with amlodipine (or another CCB) alone or with valsartan (or another ARB) alone, or with any antihypertensive monotherapy.
- •Agree to and are able to follow the study procedures
- •Understand the nature of the study, and have signed informed consent forms
排除标准
- •Patients with any of the following conditions:
- •Malignant (or history of malignant) hypertension
- •Secondary hypertension
- •Severe hypertension (mean sitting DBP ≥ 110 mmHg and/or mean sitting SBP ≥ 180 mmHg)
- •A history of hypertensive encephalopathy or cerebrovascular accident
- •Cerebrovascular accident, myocardial infraction within 3 months, or any type of revascularization
- •New York Heart Association class III -IV congestive heart failure
- •Second- or third-degree heart block
- •Angina pectoris
- •Significant arrhythmia or valvular heart disease
- •Significant pancreatic, hepatic, or renal disease
- •Diabetes requiring insulin treatment or poorly controlled type 2 diabetes
- •Patients with known contraindication or a history of allergy to CCBs or ARBs.
- •Female patients who are pregnant or lactating.
- •Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study
- •Patients is currently participating in any other clinical trial within 30 days
研究组 & 干预措施
Study group
Experimental
Amlodipine/Valsartan Single-Pill Combination
干预措施: Amlodipine/Valsartan (Drug)
结局指标
主要结局
To evaluate the change from baseline in office SBP measurements by cuff assessments at the end of the 6-week study period.
时间窗: 6 weeks from baseline
次要结局
- To evaluate the change from baseline in office DBP measurements by cuff assessments after 6 weeks of treatment(6 weeks from baseline)
- To evaluate the percentage of subjects who achieve BP goal as measured by cuff assessments (<140/90 mmHg) after 6 weeks of treatment(6 weeks from baseline)
研究者
研究点 (1)
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