Fixed-Free HTN Trial

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578042
• Other study ID #: Losanet AM Plus trial
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2018
• Source: Hotel Dieu de France Hospital
• Contact: Rabih R Azar, MD, MPH
• Phone: +9611615300
• Email: razar[@]usj.edu.lb
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Losartan and amlodipine and hydrochlorothiazide
this is a fixed combination containing the 3 drugs
• Standard of care
any free triple combination therapy for hypertension given as 2 or 3 pills

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Hotel Dieu de France Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average 24 hour blood pressure measured by ambulatory recording	Measured by ambulatory blood pressure recording over 24 hours	measured after 2 months of therapy
Secondary	central aortic blood pressure		measured after 2 months of therapy
Secondary	pulse wave velocity		measured after 2 months of therapy