Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
研究概览
简要总结
The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo.
The secondary objectives are:
- to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
- to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with placebo once a day.
干预措施: Placebo (Drug)
Irbesartan 150mg
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 150 mg once a day.
干预措施: IRBESARTAN (SR47436) (Drug)
Irbesartan 150 mg / Amlodipine 5 mg
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day.
干预措施: Irbesartan / Amlodipine (Drug)
Irbesartan 300 mg / Amlodipine 5 mg
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day.
干预措施: Irbesartan / Amlodipine (Drug)
Amlodipine
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Amlodipine 5 mg once a day.
干预措施: Amlodipine (Drug)
Irbesartan 300 mg
Active Comparator: Irbesartan
Before randomization (common with other arms):
There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.
After randomization:
8 weeks of treatment with Irbesartan 300 mg once a day.
干预措施: IRBESARTAN (SR47436) (Drug)
结局指标
主要结局
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
时间窗: At week 0, week 2, week 4 and week 8
次要结局
- Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo(At week 0, week 2, week 4 and week 8)
- Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo(At week 0, week 2, week 4)