A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 910
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).
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
- •Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
- •Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.
排除标准
- •Severe hypertension
- •History of angioedema, drug-related or otherwise, as reported by the patient.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
- •History or evidence of a secondary form of hypertension.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
VAL + AHU 400 mg
Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
干预措施: Valsartan (Drug)
VAL + AHU 400 mg
Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
干预措施: AHU377 (Drug)
VAL + AHU 200 mg
Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
干预措施: Valsartan (Drug)
VAL + AHU 200 mg
Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
干预措施: AHU377 (Drug)
VAL + AHU 100 mg
Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
干预措施: Valsartan (Drug)
VAL + AHU 100 mg
Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
干预措施: AHU377 (Drug)
VAL + AHU 50 mg
Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
干预措施: Valsartan (Drug)
VAL + AHU 50 mg
Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
干预措施: AHU377 (Drug)
VAL 320 mg
Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
干预措施: Valsartan (Drug)
LCZ 400 mg
Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
干预措施: LCZ696 (Drug)
Placebo
Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline, 8 weeks
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Mean Sitting Pulse Pressure(Baseline, 8 weeks)
- Change From Baseline in maSBP and maDBP in Non-dippers(Baseline, 8 weeks)
- Change From Baseline in Mean Diastolic Blood Pressure (msDBP)(Baseline, 8 weeks)
- Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)(Baseline, 8 weeks)
- Change From Baseline in Daytime maSBP and maDBP(Baseline, 8 weeks)
- Change From Baseline in Nighttime maSBP and maDBP(Baseline and 8 weeks)
- Change From Baseline in Mean Ambulatory Pulse Pressure(Baseline, 8 weeks)
- Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age(Baseline, 8 weeks)
- Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age(Baseline, 8 weeks)
- Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age(Baseline, 8 weeks)
- Change From Baseline in maSBP and maDBP in Dippers(Baseline, 8 weeks)
- Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response(8 weeks)
- Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age(Baseline, 8 weeks)
- Number of Participants With Adverse Events, Serious Adverse Events and Death(8 weeks)