Fixed-Free HTN Trial
- Conditions
- Hypertension
- Interventions
- Drug: Standard of care
- Registration Number
- NCT03578042
- Lead Sponsor
- Hotel Dieu de France Hospital
- Brief Summary
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
- Detailed Description
Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:
1. Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
2. 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard of care Standard of care Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician LosanetAMplus Losartan and amlodipine and hydrochlorothiazide Patients taking the fixed triple combination
- Primary Outcome Measures
Name Time Method average 24 hour blood pressure measured by ambulatory recording measured after 2 months of therapy Measured by ambulatory blood pressure recording over 24 hours
- Secondary Outcome Measures
Name Time Method central aortic blood pressure measured after 2 months of therapy pulse wave velocity measured after 2 months of therapy
Trial Locations
- Locations (1)
Hotel Dieu de France Hospital
🇱🇧Beirut, Lebanon