NCT00734630已完成4 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.
Forest Laboratories75 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2008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
- 491
- 试验地点
- 75
- 主要终点
- Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
研究概览
简要总结
This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ambulatory outpatients 18-85 years old at screening
- •Have a history of hypertension
- •Qualifying laboratory results
排除标准
- •Severe hypertension, including chronic kidney disease
- •Documented congestive heart failure
- •Have clinically significant respiratory, liver, or heart disease
- •History of stroke, heart attack, or heart surgery in the last 6 months
- •Have a history of hypersensitivity to nebivolol or other beta blockers.
研究组 & 干预措施
Nebivolol
Active Comparator
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
干预措施: nebivolol (Drug)
Placebo
Placebo Comparator
Matching placebo tablets, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12
时间窗: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)
Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).
次要结局
- Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12(From baseline Visit 5 (Week 0) to Visit 10 (Week 12))
研究者
研究点 (75)
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