Fixed-Free HTN Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-12-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LosanetAMplus

Patients taking the fixed triple combination

Group Type ACTIVE_COMPARATOR

Losartan and amlodipine and hydrochlorothiazide

Intervention Type DRUG

this is a fixed combination containing the 3 drugs

standard of care

Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician

Group Type OTHER

Standard of care

Intervention Type DRUG

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

Interventions

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Losartan and amlodipine and hydrochlorothiazide

this is a fixed combination containing the 3 drugs

Intervention Type DRUG

Standard of care

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No