Fixed-Free HTN Trial

Hotel Dieu de France Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Standard of care; Drug: Losartan and amlodipine and hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT03578042

Losanet AM Plus trial

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

LosanetAMplus

Active Comparator group

Description:

Patients taking the fixed triple combination

Treatment:

Drug: Losartan and amlodipine and hydrochlorothiazide

standard of care

Other group

Description:

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

Treatment:

Drug: Standard of care