Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study
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.
Drug: Valsartan 80mg daily
Drug: Valsartan 160mg daily
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement|
- Improvement percentage of urinary albumin excretion [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
- home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy [ Time Frame: every month ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||November 2013|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Experimental: Valsartan||Drug: Valsartan 80mg daily Drug: Valsartan 160mg daily|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460213
|Kitakyushu, Fukuoka, Japan, 808-0024|
|Study Chair:||Koshiro Fukiyama, MD||Japan Seamen's Relief Association Moji Hospital|