A Phase 4 interventional study of Valsartan and Amlodipine in Hypertension and Type 2 Diabetes Mellitus, sponsored by Nagoya University. Completed at 1 site in Japan. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-05-01.
Sponsored by Nagoya University · Phase 4, Interventional, and Prevention
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 1,150 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Nagoya University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.
Drug: Valsartan
Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.
Drug: Amlodipine
valsartan 80 to 160 mg daily
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
The record gives a start of Oct 2004, a primary completion of Jul 2010 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Valsartan · Amlodipine
Nagoya University