NCT01631864已完成2 期
A Randomized, Double-blind, Parallel Group Study to Evaluate Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
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
- 98
- 试验地点
- 1
- 主要终点
- Change From Baseline in Insulin Sensitivity Index
研究概览
简要总结
This study investigated the effects of LCZ696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Written informed consent must be obtained before any study assessment is performed.
- •Males and females of non-childbearing potential ≥ 18 years of age.
- •Subjects with mild to moderate essential hypertension,
- •Untreated subjects must have a mean seated SBP (msSBP) ≥ 130 mmHg and < 180 mmHg at screening.
- •Pre-treated subjects must have a msSBP ≤ 160 mmHg at screening and < 180 mmHg at the end of the washout period.
- •Waist circumference ≥ 102 cm (men) and ≥ 88 cm (women);
- •Exclusion criteria:
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
- •History of angioedema, drug-related or otherwise
- •History of hypersensitivity to LCZ696, amlodipine, or drugs of similar chemical classes.
- •Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
- •Type 1 or Type 2 diabetes mellitus.
- •Dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid.
- •Concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on glucose or lipid metabolism for the duration of the study.
- •Other protocol defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
LCZ696
Experimental
LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
干预措施: LCZ696 (Drug)
LCZ696
Experimental
LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
干预措施: Placebo (Drug)
amlodipine
Active Comparator
amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
干预措施: amlodipine (Drug)
amlodipine
Active Comparator
amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Insulin Sensitivity Index
时间窗: baseline, 8 weeks
The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.
次要结局
- Oxidative Metabolism(57 days)
- Local Adipose Tissue Lipolysis, Glycerol Concentrations(57 days)
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths(8 weeks)
研究者
研究点 (1)
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