Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study

Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Valsartan 80mg daily; Drug: Valsartan 160mg daily

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 808-0024
      • Koshiro Fukiyama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Valsartan	Drug: Valsartan 80mg daily; Drug: Valsartan 160mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement percentage of urinary albumin excretion	3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy	every month

Collaborators and Investigators

• Sponsor: Kitakyushu-Tsuyazaki Hospital
• Investigators: Study Chair: Koshiro Fukiyama, MD, Japan Seamen's Relief Association Moji Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: March 28, 2007
• First Submitted That Met QC Criteria: April 12, 2007
• First Posted (ESTIMATE): April 13, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: home blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: KIT-061003-1; ISRCTN1150