Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492128

Enrollment

196

Registered

2007-06-27

Start date

2007-09-30

Completion date

2010-08-31

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, angiotensin receptor blocker, diuretic, combination therapy

Brief summary

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

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.

Interventions

DRUGLosartan/amlodipine or losartan/hydrochlorothiazide

Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
The change of systolic blood pressure	three months

Secondary

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026