A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 277
- 试验地点
- 2
- 主要终点
- Change From Baseline in Trough Seated DBP at Week 8(LOCF).
研究概览
简要总结
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
- •Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
- •Meet criteria for stage I or II hypertension
- •Currently not treated, or being treated with no more than two anti-hypertensive medications
排除标准
- •Secondary hypertension
- •Are taking three or more antihypertensive agents
- •Have uncontrolled or poorly controlled diabetes mellitus type I or type II
- •Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
- •Participation in any investigational study within 30 days 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
Nebivolol
Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
干预措施: Nebivolol (Drug)
Placebo
Matching placebo tablets, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Trough Seated DBP at Week 8(LOCF).
时间窗: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)
The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.
次要结局
- Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).(From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8))