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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460213
• Other study ID #: KIT-061003-1
• Secondary ID: ISRCTN1150
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: December 5, 2013
• Start date: July 2006
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Kitakyushu-Tsuyazaki Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 2013
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Valsartan 80mg daily

• Valsartan 160mg daily

Locations

Country	Name	City	State
Japan	Koshiro Fukiyama	Kitakyushu	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kitakyushu-Tsuyazaki Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement percentage of urinary albumin excretion		3, 6, 9, and 12 months	No
Secondary	home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy		every month	No