Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Phase 4

Completed

• Conditions: Hypertension; Type 2 Diabetes Mellitus
• Interventions: Drug: Amlodipine; Drug: Valsartan

• Registration Number: NCT00129233
• Lead Sponsor: Nagoya University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-10
• Study First Submitted QC: 2005-08-10
• Study First Posted: 2005-08-11
• Primary Completion: 2010-07
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine	Amlodipine	Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.
Valsartan	Valsartan	Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.

Primary Outcome Measures

Name	Time	Method
Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death	At least 3 years of mean follow up period

Secondary Outcome Measures

Name	Time	Method
total death	At least 3 years of mean follow up period
cardiac function evaluated by ultrasonography	At least 3 years of mean follow up period
incidence of atrial fibrillation/flutter	At least 3 years of mean follow up period
control of blood glucose	At least 3 years of mean follow up period
renal function	At least 3 years of mean follow up period

Trial Locations

Locations (1)

Department of Cardiology, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Aichi, Japan