Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Hypertension Clinical Trial

Official title:

The Novel Antihypertensive Goal Of hYpertension With diAbetes ― Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129233
• Other study ID #: 169
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2005
• Last updated: April 29, 2013
• Start date: October 2004
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Nagoya University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: April 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Valsartan
valsartan 80 to 160 mg daily
• Amlodipine
Amlodipine 5 to 10 mg daily.

Locations

Country	Name	City	State
Japan	Department of Cardiology, Nagoya University Graduate School of Medicine	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	total death		At least 3 years of mean follow up period	No
Secondary	cardiac function evaluated by ultrasonography		At least 3 years of mean follow up period	No
Secondary	incidence of atrial fibrillation/flutter		At least 3 years of mean follow up period	No
Secondary	control of blood glucose		At least 3 years of mean follow up period	No
Secondary	renal function		At least 3 years of mean follow up period	No