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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Koshiro Fukiyama, Kitakyushu-Tsuyazaki Hospital
ClinicalTrials.gov Identifier:
NCT00460213
First received: March 28, 2007
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Valsartan 80mg daily
Drug: Valsartan 160mg daily
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study on Optimal Anti-hypertensive Therapy With Valsartan by Using Home Blood Pressure Measurement

Resource links provided by NLM:


Further study details as provided by Kitakyushu-Tsuyazaki Hospital:

Primary Outcome Measures:
  • Improvement percentage of urinary albumin excretion [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy [ Time Frame: every month ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: July 2006
Study Completion Date: November 2013
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460213

Locations
Japan
Koshiro Fukiyama
Kitakyushu, Fukuoka, Japan, 808-0024
Sponsors and Collaborators
Kitakyushu-Tsuyazaki Hospital
Investigators
Study Chair: Koshiro Fukiyama, MD Japan Seamen's Relief Association Moji Hospital
  More Information

No publications provided

Responsible Party: Koshiro Fukiyama, Honorary Director, Kitakyushu-Tsuyazaki Hospital
ClinicalTrials.gov Identifier: NCT00460213     History of Changes
Other Study ID Numbers: KIT-061003-1, ISRCTN1150
Study First Received: March 28, 2007
Last Updated: December 5, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Kitakyushu-Tsuyazaki Hospital:
home blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014