NCT01218100已完成4 期
A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension
Forest Laboratories90 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2010年10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
- 664
- 试验地点
- 90
- 主要终点
- The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
研究概览
简要总结
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP>= 100 mmHg).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female outpatients 18 to 64 years of age
- •Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
- •stage 2 diastolic hypertension (DBP >= 100 mmHg)
排除标准
- •secondary hypertension
- •evidence of other concurrent disease or conditions that might interfere with the conduct of the study
- •participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
- •have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use
研究组 & 干预措施
1
Experimental
Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
干预措施: nebivolol and lisinopril (free combination) (Drug)
2
Active Comparator
Nebivolol monotherapy group - starting dose level nebivolol 5mg
干预措施: nebivolol monotherapy (Drug)
3
Active Comparator
Lisinopril monotherapy group - starting dose level lisinopril 10mg
干预措施: lisinopril monotherapy (Drug)
4
Placebo Comparator
Placebo group - starting dose is placebo
干预措施: placebo (Drug)
结局指标
主要结局
The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
时间窗: Visit 6/(Week 0) and Visit 9/(Week 6)
次要结局
- The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.(Visit 6/(Week 0) and Visit 9/(Week 6))
研究者
研究点 (90)
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