A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study
研究概览
简要总结
Primary Objective:
- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure < 140 mmHg and Diastolic blood pressure <90mmHg, at the end of the study
Secondary Objectives:
- To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
- To examine the proportion of patients with controlled OBPM (systolic BP<140 mm Hg and diastolic BP<90 mmHg) of the different dose groups over time
- To determine the incidence and severity of adverse events.
详细描述
16 weeks
- V1 (week 0): Inclusion visit.
- V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit
- V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,
- V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg
- V5 (Week 16): End of study visit
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
- None
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
Irbesartan/Amlodipine 150/5 mg fixed combination
1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks.
If OBPM is controlled on monotherapy at week 4 (SBP <140 mmHg and DBP<90 mmHg), patient will be withdrawn from the study
干预措施: Irbesartan/Amlodipine (150/5mg) (Drug)
Irbesartan/Amlodipine 150/10 mg fixed combination
1 tablet once daily in the morning for 4 weeks
干预措施: Irbesartan/Amlodipine (150/10mg) (Drug)
Irbesartan/Amlodipine 300/5 mg fixed combination
1 tablet once daily in the morning for 4 weeks
干预措施: Irbesartan/Amlodipine (300/5mg) (Drug)
Irbesartan/Amlodipine 300/10 mg fixed combination
1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study
干预措施: Irbesartan/Amlodipine (300/10mg) (Drug)
结局指标
主要结局
Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study
时间窗: up to 16 weeks
次要结局
- Proportion of patients with controlled OBPM by visit and treatment group(up to 16 weeks)
- Mean change in OBPM between 2 visits(up to 16 weeks)
- Number of patients with adverse events(up to 16 weeks)
- Number of patients who discontinue from the study due to adverse events(up to 16 weeks)
- Number of patients with abnormal liver function(up to 16 weeks)