A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Proof-of-concept Study to Evaluate the Efficacy and Safety of LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 11
- 主要终点
- Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
研究概览
简要总结
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female (post-menopausal or surgically sterile).
- •Age from 18 to 75 years inclusive.
- •Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
排除标准
- •History or evidence of a secondary form of hypertension,
- •History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
- •Clinically significant valvular heart disease.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LFF269 low dose
LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period
干预措施: LFF269 (Drug)
LFF269 low dose
LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period
干预措施: Placebo (Drug)
LFF269 high dose
LFF269 high dose + Matching Placebo to Eplerenone 50mg
干预措施: LFF269 (Drug)
LFF269 high dose
LFF269 high dose + Matching Placebo to Eplerenone 50mg
干预措施: Placebo (Drug)
Eplerenone
Eplerenone 50mg twice daily + matching placebo of LFF269
干预措施: Eplerenone (Drug)
Eplerenone
Eplerenone 50mg twice daily + matching placebo of LFF269
干预措施: Placebo (Drug)
Placebo
Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
时间窗: Baseline, week 4
次要结局
- Change from baseline in mean sitting SBP and DBP after 4 weeks treatment(Baseline, week 4)
- change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment(Baseline, week 4)
- Percentage of patients experiencing adverse events during the study as measure of safety and tolerability(4 weeks)
- Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment(Baseline, week 4)
- Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment(Baseline, week 4)
- Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)(4 weeks)
- Pharmacokinetics of LFF269: Plasma concentrations of LFF269(pre dose & 6 hours post study drug dose)