Fixed-Free HTN Trial

NCT03578042 | Unknown Phase 4

• 1 other identifier: Losanet AM Plus trial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• central aortic blood pressure

  measured after 2 months of therapy

• pulse wave velocity

  measured after 2 months of therapy

Study Arms (2)

LosanetAMplus

ACTIVE COMPARATOR

Patients taking the fixed triple combination

Drug: Losartan and amlodipine and hydrochlorothiazide

standard of care

OTHER

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

Drug: Standard of care

Interventions

Losartan and amlodipine and hydrochlorothiazide DRUG

this is a fixed combination containing the 3 drugs

LosanetAMplus

Standard of care DRUG

any free triple combination therapy for hypertension given as 2 or 3 pills

standard of care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hotel Dieu de France Hospital: lead

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Amlodipine; Hydrochlorothiazide; Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rabih R Azar, MD, MPH

  Hotel Dieu de France Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabih R Azar, MD, MPH

CONTACT

+9611615300; razar@usj.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, Chief of Cardiology

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 5, 2018
• Study Start: April 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)