A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
研究概览
简要总结
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with essential hypertension, untreated or currently taking antihypertensive therapy
- •Key exclusion Criteria:
- •women of child bearing potential (WOCBP) if not on highly effective contraception
- •Malignant or severe hypertension (grade 3 of WHO classification)
- •History or evidence of a secondary form of hypertension
- •Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
- •Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
排除标准
- 未提供
研究组 & 干预措施
sacubitril/valsartan (LCZ696)
Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: sacubitril/valsartan (LCZ696) (Drug)
sacubitril/valsartan (LCZ696)
Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: placebo to olmesartan (Other)
sacubitril/valsartan (LCZ696)
Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: Amlodipine (Optional) (Drug)
olmesartan
Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: olmesartan (Drug)
olmesartan
Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: placebo to sacubitril/valsartan (LCZ696) (Other)
olmesartan
Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
干预措施: Amlodipine (Optional) (Drug)
结局指标
主要结局
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
时间窗: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Change From Baseline in Ascending Aorta Distensibility at 52 Week
时间窗: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
时间窗: Baseline, 52 weeks
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
次要结局
- Change From Baseline in Central Blood Pressure at 52 Weeks(Baseline, 52 weeks)
- Change From Baseline in Augmentation Pressure at 52 Weeks(Baseline, 52 weeks)
- Change From Baseline in Local Aortic Strain at 52 Weeks(Baseline, 52 weeks)
- Change From Baseline in Augmentation Index at 52 Weeks(Baseline, 52 weeks)
- Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks(Baseline, 52 weeks)
- Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks(Baseline, 52 weeks)
- Number of Patients With Reported Adverse Events, Serious Adverse Events and Death(12 weeks)