NCT03578042

Fixed-Free HTN Trial

Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hotel Dieu de France Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Losartan and amlodipine and hydrochlorothiazide	this is a fixed combination containing the 3 drugs
DRUG	Standard of care	any free triple combination therapy for hypertension given as 2 or 3 pills

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-09-30
• Completion: 2019-12-30
• First posted: 2018-07-05
• Last updated: 2018-07-05

Locations

1 site across 1 country: Lebanon