Back to results

Fixed-Free HTN Trial

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Lebanon

Study Type

Interventional

Intervention

Losartan and amlodipine and hydrochlorothiazide

Standard of care

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hotel Dieu de France HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

LosanetAMplus

standard of care

Arm Description

Patients taking the fixed triple combination

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

Outcomes

Primary Outcome Measures

average 24 hour blood pressure measured by ambulatory recording

Measured by ambulatory blood pressure recording over 24 hours

Secondary Outcome Measures

central aortic blood pressure

pulse wave velocity

Full Information

NCT ID

NCT03578042

First Posted

June 24, 2018

Last Updated

June 24, 2018

Sponsor

Hotel Dieu de France Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03578042

Brief Title

Fixed-Free HTN Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

September 30, 2019 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hotel Dieu de France Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

Detailed Description

Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive: Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LosanetAMplus

Arm Type

Active Comparator

Arm Description

Patients taking the fixed triple combination

Arm Title

standard of care

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Losartan and amlodipine and hydrochlorothiazide

Intervention Description

this is a fixed combination containing the 3 drugs

Intervention Type

Drug

Intervention Name(s)

Standard of care

Intervention Description

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

Primary Outcome Measure Information:

Title

average 24 hour blood pressure measured by ambulatory recording

Description

Measured by ambulatory blood pressure recording over 24 hours

Time Frame

measured after 2 months of therapy

Secondary Outcome Measure Information:

Title

central aortic blood pressure

Time Frame

measured after 2 months of therapy

Title

pulse wave velocity

Time Frame

measured after 2 months of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rabih R Azar, MD, MPH

Phone

+9611615300

Ext

9418

razar@usj.edu.lb

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabih R Azar, MD, MPH

Organizational Affiliation

Hotel Dieu de France Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hotel Dieu de France Hospital

City

Beirut

ZIP/Postal Code

Beirut

Country

Lebanon

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rabih R Azar, MD, MPH

Phone

+9611615300

Ext

9408

razar@usj.edu.lb

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fixed-Free HTN Trial

We'll reach out to this number within 24 hrs