Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Detailed Description
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The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Official Title
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Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Losartan/amlodipine or losartan/hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under treatment of hypertension with ARB monotherapy for more than one month. systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position. In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position. Exclusion Criteria: uncontrolled hypertension (diastolic blood pressure >120mmHg) uncontrolled diabetes mellitus (HbA1c>9.0%) Acute myocardial infarction, stroke and other cardiovascular events within six months The history of gout, or uric acid>8.0mg/dl Serum creatinine>2.0mg/dl sever liver dysfunction Bilateral renovascular stenosis secondary hypertension malignant hypertension uncontrolled arrhythmia pregnancy or possibility of pregnancy hypersensitivity to trial drug

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Losartan/hydrochlorothiazide<br>Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg | Drug: Losartan/amlodipine or losartan/hydrochlorothiazide<br>* Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.<br>* Other names: Preminent (Hyzaar);|
| Active Comparator: Losartan/amlodipine<br>Combination therapy with losartan 50mg and amlodopine 5mg | Drug: Losartan/amlodipine or losartan/hydrochlorothiazide<br>* Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.<br>* Other names: Preminent (Hyzaar);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of systolic blood pressure |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The achievement rate of target blood pressure |  | three months | 
| The change of diastolic blood pressure |  | three months | 
| The change of blood pressure |  | six months, nine months and one year | 
| The achievement rate of target blood pressure |  | six months, nine months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, angiotensin receptor blocker, diuretic, combination therapy