drugset / Trial / NCT00129233

Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

NCT00129233

Phase 4 Completed 1150 enrolled Nagoya University
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2004-10
Primary completion
2010-07
Completion
2013-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg
Comparator Amlodipine Other / unclassified 10 mg
Comparator Valsartan Small molecule 80 mg
Comparator Valsartan Small molecule 160 mg