Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2013-04-30

Brief Summary

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Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.

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Detailed Description

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Conditions

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Hypertension Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Valsartan

Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

valsartan 80 to 160 mg daily

Amlodipine

Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine 5 to 10 mg daily.

Interventions

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Valsartan

valsartan 80 to 160 mg daily

Intervention Type DRUG

Amlodipine

Amlodipine 5 to 10 mg daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypertension
* Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

Exclusion Criteria

* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
* Taking calcium channel blocker for the purpose of angina pectoris
* Reduced ejection fraction (\< 40%)
* Second- or third-degree of atrioventricular block
* Severe hypertension (\> 200/110 mmHg) or secondary hypertension
* History of stroke in the recent 6 months
* Serum creatinine \> 2.5 mg/dl
* Estimated survival duration less than 3 years due to other conditions
* Pregnant woman or possibly pregnant woman

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No