Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial

Study Overview
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Brief Summary
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The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Detailed Description
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Despite clear evidence that blood pressure lowering treatment is beneficial for reduction of cardiovascular disease, blood pressure levels are not adequately controlled in many hypertensive patients. More intensive blood pressure lowering treatment is required to achieve maximum reduction of cardiovascular disease. Combination pills of blood pressure lowering drugs could be a safe and effective strategy to achieve blood pressure target but there is no randomized evidence that established the beneficial effects of combination pills of blood pressure lowering drugs. The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Official Title
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A Randomized Trial to Establish the Effects of Combination Pill of Losartan Potassium and Hydrochlorothiazide on Medication Compliance Among Patients With High Blood Pressure.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Combination pill of losartan and hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20 years or above Hypertension defined as blood pressure levels of >/=140/90mmHg or current use of blood pressure lowering drugs Able to commence combination therapy of angiotensin receptor antagonists and diuretics Exclusion Criteria: Blood pressure measurements of >/=200/120mmHg Previous serious adverse events due to angiotensin receptor antagonists or diuretics Known or possible pregnancy Known severe liver dysfunction Known severe kidney disease Known contraindication to angiotensin receptor antagonists or diuretics Taking >/=4 tablets except for angiotensin receptor antagonists ACE inhibitors, thiazide or thiazide-like diuretics in the morning Current participation in another clinical trial A high likelihood that the patient is not suitable for the study treatment

Ages Eligible for Study
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Minimum Age: 20 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: Combination pill<br>Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning | Drug: Combination pill of losartan and hydrochlorothiazide<br>* Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning<br>* Other names: Preminent;|
| No Intervention: Control group<br>combination therapy of angiotensin receptor antagonists (losartan potassium 50mg, candesartan 8mg, valsartan 80mg, telmisartan 40mg or olmesartan 20mg) and thiazide or thiazide-like diuretics (hydrochlorothiazide 6.25-12.5mg, trichlormethiazide 0.5-1.0mg, indapamide 0.5-1.0mg or chlorthalidone 6.25-12.5mg) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication compliance |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 6 months | 
| cost of blood pressure lowering drugs |  | 6 months | 
| serious adverse events |  | 6 months | 
| adverse events |  | 6 months | 
| blood test |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, combination pill, compliance