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OpenTrials
Completed

NCT Number: NCT00129233

Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

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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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, 466-8550, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

valsartan 80 to 160 mg daily

Amlodipine

Drug

Amlodipine 5 to 10 mg daily.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nagoya University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2013
First posted
Aug 11, 2005
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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