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Clinical Trial Summary

The purpose of this study is to compare improvement percentage of urinary albumin excretion between valsartan 80 mg- and valsartan 160 mg-based therapy in patient with morning hypertension.


Clinical Trial Description

The cardiovascular diseases such as stroke and myocardial infarction consist 50% of the cause of death in Japanese population. Numerous mega trials have shown that strict anti-hypertensive therapy could reduce cardiovascular morbidity and mortality in hypertensive patients.

It is reported, however, over 50% hypertensive patients have not been controlled below therapeutic target blood pressure that the JSH2004 guideline recommends.

Recently use of Angiotensin II receptor blockers (ARBs) is increasing progressively for their pharmacological action on organ protection as well as potent reduction in blood pressure. However, usual dosage of ARB in Japan is almost half of that in the mega trials executed in Europe and America. Lower dosage compared to western countries might be a reason why cardiovascular events are not fully reduced in Japan.

Valsartan optimal therapy against elevated home blood pressure research (VOYAGER) study will be a multi-center, open-label, randomized, active-controlled study to evaluate the following; improvement percentage of urinary albumin exception, home blood pressure, hospital blood pressure, incidence of stroke, cardiovascular disease, and microangiopathy with valsartan 80 mg- or valsartan 160 mg based therapy in patients with elevated morning home blood pressure. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00460213
Study type Interventional
Source Kitakyushu-Tsuyazaki Hospital
Contact
Status Completed
Phase Phase 4
Start date July 2006
Completion date November 2013

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