A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,161
- 试验地点
- 413
- 主要终点
- Change in Sitting Diastolic Blood Pressure (DBP)
研究概览
简要总结
To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 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
- Triple (Participant, 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
- •Male or female outpatients of age 18 years or above
- •Patients diagnosed with stage 1 or stage 2 essential hypertension
- •Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
排除标准
- •Secondary hypertension or severe hypertension
- •Clinically significant cardiovascular disease or heart failure
- •Clinical significant respiratory disease that would prohibit the use of a beta blocker
- •A medical contraindication to discontinuing a current antihypertensive therapy
- •History of Type 1 diabetes mellitus
- •History of Severe Mental Illness except mild depression
研究组 & 干预措施
Nebivolol and Valsartan Fixed Dose Combination 1
Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
干预措施: Nebivolol and Valsartan 1 (Drug)
Nebivolol and Valsartan Fixed Dose Combination 2
Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
干预措施: Nebivolol and Valsartan 2 (Drug)
Nebivolol and Valsartan Fixed Dose Combination 3
Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
干预措施: Nebivolol and Valsartan 3 (Drug)
Nebivolol Low Dose
Nebivolol Monotherapy 5 mg
干预措施: Nebivolol 1 (Drug)
Nebivolol High Dose
Nebivolol Monotherapy 20 mg
干预措施: Nebivolol 2 (Drug)
Valsartan Low Dose
Valsartan Monotherapy 80 mg
干预措施: Valsartan 1 (Drug)
Valsartan High Dose
Valsartan Monotherapy 160 mg
干预措施: Valsartan 2 (Drug)
Placebo
Dose Matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Sitting Diastolic Blood Pressure (DBP)
时间窗: from basline to Week 8
次要结局
- Change in Sitting Systolic Blood Pressure (SBP)(from baseline to Week 8)