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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Kitakyushu-Tsuyazaki Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kitakyushu-Tsuyazaki Hospital
ClinicalTrials.gov Identifier:
NCT00460213
First received: March 28, 2007
Last updated: April 12, 2007
Last verified: April 2007
History of Changes
  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:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Kitakyushu-Tsuyazaki Hospital:

Primary Outcome Measures:
  • Improvement percentage of urinary albumin excretion

Secondary Outcome Measures:
  • home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy

Estimated Enrollment: 1000
Study Start Date: July 2006
Estimated Study Completion Date: June 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460213

Contacts
Contact: Isao Abe, MD +81-93-761-3936 abeisao@k3.dion.ne.jp

Locations
Japan
Koshiro Fukiyama Recruiting
1-3-1,Kiyotaki Moji-ku,,Kitakyusyu-city, Fukuoka, Japan, 808-0024
Contact: Isao Abe, MD     +81-93-761-3936     abeisao@k3.dion.ne.jp    
Contact: Masaharu Ikeda, MD     +81-940-52-0034     drikeda@kitakyu-hp.or.jp    
Principal Investigator: Hiroshi Yamato, M.D.            
Sub-Investigator: Nobuyuki Kawazoe, M.D.            
Sub-Investigator: Takashi Inenaga, M.D.            
Sponsors and Collaborators
Kitakyushu-Tsuyazaki Hospital
Investigators
Study Chair: Koshiro Fukiyama, MD Japan Seamen's Relief Association Moji Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00460213     History of Changes
Other Study ID Numbers: KIT-061003-1, ISRCTN1150
Study First Received: March 28, 2007
Last Updated: April 12, 2007
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 May 16, 2013