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

March 28, 2007
December 5, 2013
July 2006
December 2008   (final data collection date for primary outcome measure)
Improvement percentage of urinary albumin excretion [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Improvement percentage of urinary albumin excretion
Complete list of historical versions of study NCT00460213 on ClinicalTrials.gov Archive Site
home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy [ Time Frame: every month ] [ Designated as safety issue: No ]
home blood pressure; hospital blood pressure; stroke; cardiovascular disease; microangiopathy
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypertension
  • Drug: Valsartan 80mg daily
  • Drug: Valsartan 160mg daily
Experimental: Valsartan
Interventions:
  • Drug: Valsartan 80mg daily
  • Drug: Valsartan 160mg daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
November 2013
December 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00460213
KIT-061003-1, ISRCTN1150
Yes
Koshiro Fukiyama, Kitakyushu-Tsuyazaki Hospital
Kitakyushu-Tsuyazaki Hospital
Not Provided
Study Chair: Koshiro Fukiyama, MD Japan Seamen's Relief Association Moji Hospital
Kitakyushu-Tsuyazaki Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP