Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

April 29, 2013 updated by: TOYOAKI MUROHARA, Nagoya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 466-8550
        • Department of Cardiology, Nagoya University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Valsartan
Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.
Drug: Valsartan
valsartan 80 to 160 mg daily
Active Comparator: Amlodipine
Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.
Drug: Amlodipine
Amlodipine 5 to 10 mg daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At least 3 years of mean follow up period
At least 3 years of mean follow up period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya University

Investigators

  • Principal Investigator: Toyoaki Murohara, MD, PhD, Department of Cardiology, Nagoya University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria

August 10, 2005

First Posted (Estimate)

August 11, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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