Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Tokai National Higher Education and Research System

Status and phase

Completed

Phase 4

Conditions

Hypertension

Type 2 Diabetes Mellitus

Treatments

Drug: Valsartan

Drug: Amlodipine

Study type

Interventional

Funder types

Other

Identifiers

NCT00129233

169

Details and patient eligibility

About

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.

Enrollment

1,150 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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