Fixed-Free HTN Trial

Hotel Dieu de France Hospital100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hypertension

Interventions

Losartan and amlodipine and hydrochlorothiazideDRUG

this is a fixed combination containing the 3 drugs

Standard of careDRUG

any free triple combination therapy for hypertension given as 2 or 3 pills

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Hotel Dieu de France Hospital

Beirut, Lebanon

RECRUITING

Outcomes

Primary Outcomes

average 24 hour blood pressure measured by ambulatory recording

Measured by ambulatory blood pressure recording over 24 hours

Time frame: measured after 2 months of therapy

Secondary Outcomes

central aortic blood pressure

Time frame: measured after 2 months of therapy

pulse wave velocity

Time frame: measured after 2 months of therapy

Central Contacts

Rabih R Azar, MD, MPH

CONTACT

+9611615300 razar@usj.edu.lb

Data from ClinicalTrials.gov

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