Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- average 24 hour blood pressure measured by ambulatory recording
研究概览
简要总结
Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension
详细描述
Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:
- Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
- Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.
We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled* Or patients on monotherapy and who have a BP > 160/100 mm Hg
- •BP is defined as UNCONTROLLED if > 135/85 at home or > 140/90 in clinic on at least 2 occasions
排除标准
- •Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction < 3 months old Permanent atrial fibrillation Ejection fraction < 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with > 3 drugs
研究组 & 干预措施
LosanetAMplus
Patients taking the fixed triple combination
干预措施: Losartan and amlodipine and hydrochlorothiazide (Drug)
standard of care
Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician
干预措施: Standard of care (Drug)
结局指标
主要结局
average 24 hour blood pressure measured by ambulatory recording
时间窗: measured after 2 months of therapy
Measured by ambulatory blood pressure recording over 24 hours
次要结局
- central aortic blood pressure(measured after 2 months of therapy)
- pulse wave velocity(measured after 2 months of therapy)
研究者
Rabih Azar
MD, MPH, Chief of Cardiology
Hotel Dieu de France Hospital