Fixed-Free HTN Trial

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Losartan and amlodipine and hydrochlorothiazide
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LosanetAMplus<br>Patients taking the fixed triple combination | Drug: Losartan and amlodipine and hydrochlorothiazide<br>* this is a fixed combination containing the 3 drugs<br>|
| Other: standard of care<br>Patients taking 2 or 3 free combinations containing 3 drugs for hypertension as decided by the treating physician | Drug: Standard of care<br>* any free triple combination therapy for hypertension given as 2 or 3 pills<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| central aortic blood pressure |  | measured after 2 months of therapy | 
| pulse wave velocity |  | measured after 2 months of therapy |