Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00460213|
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : December 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Valsartan 80mg daily Drug: Valsartan 160mg daily||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||November 2013|
|Experimental: Valsartan||Drug: Valsartan 80mg daily Drug: Valsartan 160mg daily|
- Improvement percentage of urinary albumin excretion [ Time Frame: 3, 6, 9, and 12 months ]
- home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy [ Time Frame: every month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460213
|Kitakyushu, Fukuoka, Japan, 808-0024|
|Study Chair:||Koshiro Fukiyama, MD||Japan Seamen's Relief Association Moji Hospital|