NCT01415531已完成4 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension
Forest Laboratories75 个研究点 分布在 1 个国家目标入组 641 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 641
- 试验地点
- 75
- 主要终点
- Trough Seated Diastolic Blood Pressure (DBP)
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients, of age 18 - 54 years
- •Patients diagnosed with stage 1 or stage 2 essential hypertension
- •Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant
排除标准
- •Secondary hypertension or severe hypertension
- •History of Type 1 diabetes mellitus
- •A medical contraindication to discontinuing a current antihypertensive therapy
- •Clinically significant respiratory disease that prohibit use of a beta blocker
研究组 & 干预措施
2
Placebo Comparator
Dose-matched placebo
干预措施: Placebo (Drug)
1
Experimental
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
干预措施: Nebivolol (Drug)
结局指标
主要结局
Trough Seated Diastolic Blood Pressure (DBP)
时间窗: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
次要结局
- Trough Seated Systolic Blood Pressure (SBP)(Change from Baseline to Week 8)
研究者
研究点 (75)
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