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Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129233
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
TOYOAKI MUROHARA, 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.

Condition or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Mellitus Drug: Valsartan Drug: Amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Study Start Date : October 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. total death [ Time Frame: At least 3 years of mean follow up period ]
  2. cardiac function evaluated by ultrasonography [ Time Frame: At least 3 years of mean follow up period ]
  3. incidence of atrial fibrillation/flutter [ Time Frame: At least 3 years of mean follow up period ]
  4. control of blood glucose [ Time Frame: At least 3 years of mean follow up period ]
  5. renal function [ Time Frame: At least 3 years of mean follow up period ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129233

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Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya, Aichi, Japan, 466-8550
Sponsors and Collaborators
Nagoya University
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Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: TOYOAKI MUROHARA, Proffesor, Nagoya University Identifier: NCT00129233    
Other Study ID Numbers: 169
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
Keywords provided by TOYOAKI MUROHARA, Nagoya University:
cardiovascular disease
rennin-angiotensin system
calcium channel blocker
impaired glucose tolerance
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists