NCT01355367已完成3 期
A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 120
- 主要终点
- Safety variables will be summarized using descriptive statistics based on adverse events collection
研究概览
简要总结
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
排除标准
- •Patients with expected difficulties for the continuous 1 year follow up
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nifedipine (Adalat, BAYA1040) (Drug)
结局指标
主要结局
Safety variables will be summarized using descriptive statistics based on adverse events collection
时间窗: Week 52
次要结局
- Changes from baseline in diastolic blood pressure (DBP) while sitting(Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52)
- Changes from baseline in systolic blood pressure (SBP) while sitting(Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines(Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP(Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52)
研究者
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