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.|
|ClinicalTrials.gov Identifier: NCT00129233|
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : May 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Type 2 Diabetes Mellitus||Drug: Valsartan Drug: Amlodipine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Valsartan
Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.
valsartan 80 to 160 mg daily
Active Comparator: Amlodipine
Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.
Amlodipine 5 to 10 mg daily.
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00129233
|Department of Cardiology, Nagoya University Graduate School of Medicine|
|Nagoya, Aichi, Japan, 466-8550|
|Principal Investigator:||Toyoaki Murohara, MD, PhD||Department of Cardiology, Nagoya University Graduate School of Medicine|