NCT01415505已完成3 期
A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension
Forest Laboratories135 个研究点 分布在 1 个国家目标入组 812 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 812
- 试验地点
- 135
- 主要终点
- Adverse Event Recording
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A medical contraindication to discontinuing a current antihypertensive therapy
- •History of Type 1 diabetes mellitus
研究组 & 干预措施
1
Other
Nebivolol and Valsartan free tablet combination
干预措施: Nebivolol, Valsartan and Hydrochlorothiazide (Drug)
结局指标
主要结局
Adverse Event Recording
时间窗: From Baseline to Week 53 (Visit 16)
次要结局
- Systolic Blood Pressure (SBP)(From Baseline to Week 52 (Visit 15))
- Diastolic Blood Pressure (DBP).(From Baseline to Week 52 (Visit 15))
研究者
研究点 (135)
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