drugset / Trial / NCT00129233
Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
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
- Background Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.
- Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.
- Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.
- Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 5 mg | — |
| Comparator | Amlodipine | Other / unclassified | 10 mg | — |
| Comparator | Valsartan | Small molecule | 80 mg | — |
| Comparator | Valsartan | Small molecule | 160 mg | — |