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Comparison of Valsartan with Amlodipine in Hypertensive Patients with Glucose Intolerance - Article


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Valsartan

Diovan 



Clinical Trial: Comparison of Valsartan with Amlodipine in Hypertensive Patients with Glucose Intolerance

This study is currently recruiting patients.
Verified by Nagoya University February 2005

Sponsored by: Nagoya University
Information provided by: Nagoya University
ClinicalTrials.gov Identifier: NCT00129233

Purpose

Various guidelines recommended angiotensin converting enzyme (ACE) inhibitor or angiotensin Ⅱ receptor-1 blocker (ARB) for hypertensive patients with diabetes on the basis of cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese, because Japan has been known as a country with low incidence of coronary artery disease and high incidence of cerebrovascular disease. Furthermore, calcium channel blocker (CCB) also was protective against renal function as well as ACE inhibitor in Japanese diabetic hypertensive patients. This study will test which of ARB or CCB is superior in treating Japanese diabetic hypertensive patients.
Condition Intervention Phase
Hypertension
Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
  Drug: Valsartan (drug)
 Drug: Amlodipine (drug)
 Phase IV

MedlinePlus related topics:  Diabetes;   Genetic Disorders;   High Blood Pressure;   Metabolic Disorders

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: The Novel Antihypertensive Goal Of hYpertension with diAbetes ― Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study

Further Study Details: 
Primary Outcomes: fatal or non-fatal myocardial infarction; fatal or non-fatal stroke; admission due to congestive heart failure; coronary revascularization; sudden cardiac death
Secondary Outcomes: total death; cardiac function evaluated by ultrasonography; incidence of atrial fibrillation/flutter; control of blood glucose; renal function

Study start: October 2004

Eligibility

Ages Eligible for Study:  30 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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 possible pregnant woman

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129233

Toyoaki Murohara, MD, PhD      81-52-744-2149    murohara@med.nagoya-u.ac.jp

Japan, Aichi
      Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya,  Aichi,  466-8550,  Japan; Recruiting
Toyoaki Murohara, MD, PhD  81-52-744-2149    murohara@med.nagoya-u.ac.jp 
Toyoaki Murohara, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Toyoaki Murohara, MD, PhD,  Principal Investigator,  Department of Caldiology, Nagoya University Graduate School of Medicine   

More Information

Publications

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.

Study ID Numbers:  169
Last Updated:  August 10, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129233
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-23


Source: ClinicalTrials.gov
Cache Date: August 24, 2005

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Page Updated: June 1, 2005
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