NCT01057251已完成4 期
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension
Forest Laboratories36 个研究点 分布在 1 个国家目标入组 433 人开始时间: 2010年3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
- 433
- 试验地点
- 36
- 主要终点
- Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
研究概览
简要总结
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male of female, 18 to 64 years of age at screening
- •mean seated heart rate at least 60 bpm
- •diagnosed systolic stage 2 hypertension
- •unremarkable physical exam findings
排除标准
- •high risk due to secondary hypertension or former stage 3 hypertension by JNC6
- •concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
- •currently taking medication that cannot be stopped during the course of the study
- •participating other clinical trials
- •member of the study center personnel
- •documented drug abuse
- •contra indication to beta blocker
- •abnormal lab finding
- •poor compliance
- •other conditions judged by investigator that is not suitable for the study
研究组 & 干预措施
1
Experimental
干预措施: Nebivolol (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
时间窗: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
时间窗: Change from Baseline (Week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.
次要结局
未报告次要终点
研究者
研究点 (36)
Loading locations...
相似试验
进行中（未招募）
不适用
A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 1-5 years old with hypertension, followed by a 2 week placebo withdrawal period. - NDhypertensionEUCTR2006-005261-19-ITOVARTIS FARMA75
进行中（未招募）
不适用
Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s type under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)mild to moderate Alzheimer´s diseaseEUCTR2007-007134-19-DEOctapharma AG56
进行中（未招募）
不适用
A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 µg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 µg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 µg twice daily in adult and adolescent asthmatics - ESTHERMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaasthmaEUCTR2007-002734-11-HUAstraZeneca AB600
进行中（未招募）
1 期
A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 µg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 µg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 µg twice daily in adult and adolescent asthmaticsMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaasthmaEUCTR2007-002734-11-CZAstraZeneca AB600
进行中（未招募）
1 期
A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 µg twice daily compared with 1 inhalation Symbicort Turbuhaler® 80/4.5 µg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 µg twice daily in adult and adolescent asthmaticsasthmaEUCTR2007-002734-11-PLAstraZeneca AB600