Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study
Information source: Kitakyushu-Tsuyazaki Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan 80mg daily (Drug); Valsartan 160mg daily (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Kitakyushu-Tsuyazaki Hospital Official(s) and/or principal investigator(s):
Koshiro Fukiyama, MD, Study Chair, Affiliation: Japan Seamen's Relief Association Moji Hospital
Overall contact:
Isao Abe, MD, Phone: +81-93-761-3936, Email: abeisao@k3.dion.ne.jp
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 Details
Official title: Study on Optimal Anti-Hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Improvement percentage of urinary albumin excretion
Secondary outcome: home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Outpatients aged over 20 years and less than 80 years, regardless of sex.
- Patients with stable seated morning home blood pressure of over 135 mmHg and/or
diastolic blood pressure of over 85 mmHg within 1 to 2 weeks.
- Patients who are on therapy with conventional dosage of ARB.
Exclusion Criteria:
- Patients who are difficult to measure home blood pressure.
- Patients with secondary hypertension or malignant hypertension.
- Patients with seated systolic blood pressure of over 200 mmHg.
- Patients with seated diastolic blood pressure of over 120 mmHg.
- Patients with a history of cerebrovascular disorder or myocardial infarction or heart
failure within 6 months prior to enrolment in the study.
- Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
- Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
- Patients with serious liver dysfunction.
- Patient with HbA1C of over 8 percent.
- Patient with positive albuminuria by dip and read stick test.
- Patient treated with any angiotensin converting enzyme inhibitor
- Pregnant women
- Patients with a history of hypersensitivity to valsartan.
- Other patients who are judged to be inappropriate for the study by the investigator
or sub-investigator.
Locations and Contacts
Isao Abe, MD, Phone: +81-93-761-3936, Email: abeisao@k3.dion.ne.jp
Koshiro Fukiyama, 1-3-1,Kiyotaki Moji-ku,,Kitakyusyu-city, Fukuoka 808-0024, Japan; Recruiting
Isao Abe, MD, Phone: +81-93-761-3936, Email: abeisao@k3.dion.ne.jp
Masaharu Ikeda, MD, Phone: +81-940-52-0034, Email: drikeda@kitakyu-hp.or.jp
Hiroshi Yamato, M.D., Principal Investigator
Nobuyuki Kawazoe, M.D., Sub-Investigator
Takashi Inenaga, M.D., Sub-Investigator
Additional Information
Starting date: July 2006
Last updated: April 12, 2007
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