NCT00415623已完成3 期
A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2007年1月最近更新:
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
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
研究概览
简要总结
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
- •Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
- •Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
- •Patients with a screening treatment compliance rate >= 80%
排除标准
- •Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
研究组 & 干预措施
Amlodipine 5mg
Active Comparator
干预措施: Amlodipine (Drug)
Amlodipine 10mg
Experimental
干预措施: Amlodipine (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
时间窗: Baseline to Week 8
Mean change in the trough SBP
次要结局
- Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8(Week 8)
- Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8(Baseline to Week 8)
- Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)(Baseline to Week 6 and Week 8)
- Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8(Week 6 and Week 8)
- Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8(Week 8)
- Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)(Baseline to Week 6 and Week 8)
- Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg(Baseline, Week 4 and Week 8)
- Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg(Baseline, Week 4, and Week 8)
- Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8(Week 6 and Week 8)
研究者
研究点 (1)
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