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

August 10, 2005
April 29, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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 ]
  • total death
  • cardiac function evaluated by ultrasonography
  • incidence of atrial fibrillation/flutter
  • control of blood glucose
  • renal function
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
1150
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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00129233
169
Yes
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