Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334724
Status:
WITHDRAWN
Last Update Posted:
2015-12-29
First Post:
2006-06-07
Brief Title:
Home Blood Pressure-guided Antihypertensive Intervention for Elderly HBP-GUIDE Study
Sponsor:
Kyoto University Graduate School of Medicine
Organization:
Kyoto University Graduate School of Medicine
Study Overview
Official Title:
Home Blood Pressure-guided Antihypertensive Intervention for Elderly HBP-GUIDE Study
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients were not appropriately enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether blood pressure control by home blood pressure monitoring exerts beneficial cardioprotective effects rather than by clinic blood pressure monitoring in elderly patients
Detailed Description:
Home blood pressure BP measurement has been reported to be closely correlated with target organ damage and appears to be a prognostic indicator with respect to cardiovascular mortality and cardiovascular events However whether BP control by home BP monitoring exerts cardioprotective effects rather than by clinic BP monitoring in elderly patients remains unknown In this study a total of 500 elderly patients diagnosed with essential hypertension will be randomly divided into 2 groups target BP level home SBP 135 mmHg and home DBP 85 mmHg home BP control group clinic SBP 140 mmHg and clinic DBP 90 mmHg clinic BP control group Olmesartan at doses of 20 mgday will be administered and increased up to 40 mg if antihypertensive effect is inadequate Study visits will be made bimonthly for at least 1 year The antihypertensive and cardioprotective effects including systemic levels of C-reactive protein and inflammatory cytokines and arterial stiffness will be compared between the two groups
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