Status:
COMPLETED
Valsartan in Elderly Isolated Systolic Hypertension Study
Lead Sponsor:
VALISH study
Collaborating Sponsors:
Japan Cardiovascular Research Foundation
Conditions:
Aged
Systolic Hypertension
Eligibility:
All Genders
70-85 years
Phase:
PHASE4
Brief Summary
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 elderl...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
3079 Patients enrolled
Trial Details
Trial ID
NCT00151229
Start Date
October 1 2003
End Date
March 1 2008
Last Update
June 4 2015
Active Locations (1)
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1
VALISH Data Center
ING Corporation, 8-21, Shinjuku-ku, Tokyo, Japan, 162-0067