Fixed-Free HTN Trial

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT03578042
Study type	Interventional
Source	Hotel Dieu de France Hospital
Contact	Rabih R Azar, MD, MPH
Phone	+9611615300
Email	razar@usj.edu.lb
Status	Recruiting
Phase	Phase 4
Start date	April 1, 2017
Completion date	December 30, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.