Hypertension
Conditions
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
Interventions
DRUGLosartan and amlodipine and hydrochlorothiazide
this is a fixed combination containing the 3 drugs
DRUGStandard of care
any free triple combination therapy for hypertension given as 2 or 3 pills
Sponsors
Hotel Dieu de France Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| central aortic blood pressure | measured after 2 months of therapy |
| pulse wave velocity | measured after 2 months of therapy |
Countries
Lebanon
Contacts
Primary ContactRabih R Azar, MD, MPH
Outcome results
None listed