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Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TOYOAKI MUROHARA, Nagoya University
ClinicalTrials.gov Identifier:
NCT00129233
First received: August 10, 2005
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Type 2 Diabetes Mellitus
 Drug: Valsartan
Drug: Amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Novel Antihypertensive Goal Of hYpertension With diAbetes ― Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nagoya University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total death [ Time Frame: At least 3 years of mean follow up period ] [ Designated as safety issue: No ]
  • cardiac function evaluated by ultrasonography [ Time Frame: At least 3 years of mean follow up period ] [ Designated as safety issue: No ]
  • incidence of atrial fibrillation/flutter [ Time Frame: At least 3 years of mean follow up period ] [ Designated as safety issue: No ]
  • control of blood glucose [ Time Frame: At least 3 years of mean follow up period ] [ Designated as safety issue: No ]
  • renal function [ Time Frame: At least 3 years of mean follow up period ] [ Designated as safety issue: No ]

Enrollment: 1150
Study Start Date: October 2004
Study Completion Date: April 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129233

Locations
Japan
Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, Aichi, Japan, 466-8550
Sponsors and Collaborators
Nagoya University
Investigators
Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TOYOAKI MUROHARA, Proffesor, Nagoya University
ClinicalTrials.gov Identifier: NCT00129233     History of Changes
Other Study ID Numbers: 169
Study First Received: August 10, 2005
Last Updated: April 29, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nagoya University:
cardiovascular disease
rennin-angiotensin system
calcium channel blocker
impaired glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Valsartan
 Antihypertensive Agents
Amlodipine
Calcium Channel Blockers
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013