Clinical trial NCT00492128: Kanagawa Combination Anti-hypertensive Therapy (K-CAT)
Official title: Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
angiotensin receptor blocker
diuretic
combination therapy
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of systolic blood pressure
timeFrame: three months
Secondary outcomes:
measure: The achievement rate of target blood pressure
timeFrame: three months
measure: The change of diastolic blood pressure
timeFrame: three months
measure: The change of blood pressure
timeFrame: six months, nine months and one year
measure: The achievement rate of target blood pressure
timeFrame: six months, nine months and one year
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Graduate School of Medicine
state: Kanagawa
Study officials:
affiliation: Yokohama City University Graduate School of Medicine
name: Satoshi Umemura, MD, PhD
role: STUDY_CHAIR
References: