Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151229
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2005-09-07
Brief Title:
Valsartan in Elderly Isolated Systolic Hypertension Study
Sponsor:
VALISH study
Organization:
VALISH study
Study Overview
Official Title:
Valsartan in Elderly Isolated Systolic Hypertension
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALISH
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 elderly isolated systolic hypertensive patients in Japan
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 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 3000 and the duration of follow-up is at least 2 years This 3000-patient trial was designed with a two-sided α level of 005 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 2151000 patient-years and 2911000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None