NCT01264692已完成2 期
A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 18
- 主要终点
- Change in mean(c) trough(d) SiDBP
研究概览
简要总结
The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 to 75 years (inclusive) at screening.
- •Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
- •12-lead ECG without clinically relevant abnormalities measured at screening.
- •Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
- •Signed informed consent in the local language prior to any study-mandated procedure
排除标准
- •Mean SBP > 180 mmHg.
- •Severe, malignant, or secondary hypertension.
- •Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
- •E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
- •Angina pectoris within 6 months prior to enrollment
研究组 & 干预措施
Treatment A
Experimental
ACT-280778
干预措施: ACT-280778 (Drug)
Treatment B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Treatment C
Other
Amlodipine
干预措施: Amlodipine (Drug)
结局指标
主要结局
Change in mean(c) trough(d) SiDBP
时间窗: Baseline to day 28
Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.
次要结局
- Change in mean trough SiSBP.(Baseline to Day 28)
研究者
研究点 (18)
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