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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Valsartan 80mg daily
Valsartan 160mg daily
Sponsored by
Kitakyushu-Tsuyazaki Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring home blood pressure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Koshiro Fukiyama

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valsartan

Arm Description

Outcomes

Primary Outcome Measures

Improvement percentage of urinary albumin excretion

Secondary Outcome Measures

home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy

Full Information

First Posted
March 28, 2007
Last Updated
December 5, 2013
Sponsor
Kitakyushu-Tsuyazaki Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00460213
Brief Title
Valsartan Optimal Therapy Against Elevated Home Blood Pressure Research（VOYAGER）Study
Official Title
Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kitakyushu-Tsuyazaki Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
home blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valsartan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valsartan 80mg daily
Intervention Type
Drug
Intervention Name(s)
Valsartan 160mg daily
Primary Outcome Measure Information:
Title
Improvement percentage of urinary albumin excretion
Time Frame
3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy
Time Frame
every month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koshiro Fukiyama, MD
Organizational Affiliation
Japan Seamen's Relief Association Moji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Koshiro Fukiyama
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
808-0024
Country
Japan

12. IPD Sharing Statement

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

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