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Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

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ClinicalTrials.gov 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

August 10, 2005
August 11, 2005
May 1, 2013
October 2004
July 2010   (Final data collection date for primary outcome measure)
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 ]
  • fatal or non-fatal myocardial infarction
  • fatal or non-fatal stroke
  • admission due to congestive heart failure
  • coronary revascularization
  • sudden cardiac death
Complete list of historical versions of study NCT00129233 on ClinicalTrials.gov Archive Site
  • total death [ Time Frame: 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 ]
  • incidence of atrial fibrillation/flutter [ Time Frame: At least 3 years of mean follow up period ]
  • control of blood glucose [ Time Frame: At least 3 years of mean follow up period ]
  • renal function [ Time Frame: At least 3 years of mean follow up period ]
  • total death
  • cardiac function evaluated by ultrasonography
  • incidence of atrial fibrillation/flutter
  • control of blood glucose
  • renal function
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Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Hypertension
  • Type 2 Diabetes Mellitus
  • Drug: Valsartan
    valsartan 80 to 160 mg daily
  • Drug: Amlodipine
    Amlodipine 5 to 10 mg daily.
  • Active Comparator: Valsartan
    Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.
    Intervention: Drug: Valsartan
  • Active Comparator: Amlodipine
    Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.
    Intervention: Drug: Amlodipine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2013
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
TOYOAKI MUROHARA, Nagoya University
Nagoya University
Not Provided
Principal Investigator: Toyoaki Murohara, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
Nagoya University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP