Fixed-Free HTN Trial

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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: Losartan and amlodipine and hydrochlorothiazide; Drug: Standard of care

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, Beirut
    • Recruiting
    • Hotel Dieu de France Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: LosanetAMplus; Patients taking the fixed triple combination	Drug: Losartan and amlodipine and hydrochlorothiazide; this is a fixed combination containing the 3 drugs
OTHER: standard of care; Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician	Drug: Standard of care; any free triple combination therapy for hypertension given as 2 or 3 pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
central aortic blood pressure	measured after 2 months of therapy
pulse wave velocity	measured after 2 months of therapy

Collaborators and Investigators

• Sponsor: Hotel Dieu de France Hospital
• Investigators: Principal Investigator: Rabih R Azar, MD, MPH, Hotel Dieu de France Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: June 24, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2018
• Last Update Submitted That Met QC Criteria: June 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: Losanet AM Plus trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No