The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.

Condition	Intervention	Phase
Elderly Isolated Systolic Hypertension	Drug: Target blood pressure: <140mmHg  Drug: Target blood pressure: <150mmHg	Phase IV

Further Study Details: 

Primary Outcomes: composite cardiovascular events as followed;; 1)sudden death; 2)fatal or nonfatal stroke; 3)fatal or nonfatal myocardial infarction; 4)death due to heart failure; 5)other cardiovascular death; 6)unplanned hospitalization for cardiovascular disease; 7)renal disorder
Secondary Outcomes: sudden death; stroke; myocardial infarction; heart failure; hospitalization; renal disorder
Expected Total Enrollment:  3000

Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

Ages Eligible for Study:  70 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Outpatients aged over 70 years and less than 85 years, regardless of sex.
• Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
• Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Exclusion Criteria:

• 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 90 mmHg.
• Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
• Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.
• Patients with severe heart failure (NYHA functional classification III and IV).
• Patients with severe aortic stenosis or valvular disease.
• 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.
• 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.

Japan, Tokyo
      VALISH Data Center, ING Corporation, 8-21, Shinjuku-ku,  Tokyo,  162-0067,  Japan

Study chairs or principal investigators

Toshio Ogihara, MD, PhD,  Principal Investigator,  Department of Geriatric Medicine, Osaka University Graduate School of Medicine   
Takao Saruta, MD, PhD,  Principal Investigator,  Department of Internal Medicine, Keio University School of Medicine   

Study ID Numbers:  VAL-200310
Last Updated:  September 7, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151229
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13