Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

Yokohama City University Medical Center

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Losartan/amlodipine or losartan/hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT00492128

200706001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 196 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Losartan/hydrochlorothiazide

Experimental group

Description:

Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg

Treatment:

Drug: Losartan/amlodipine or losartan/hydrochlorothiazide

Losartan/amlodipine

Active Comparator group

Description:

Combination therapy with losartan 50mg and amlodopine 5mg

Treatment:

Drug: Losartan/amlodipine or losartan/hydrochlorothiazide