Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460915
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2007-04-16
Brief Title:
Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years
Sponsor:
Korea University Guro Hospital
Organization:
Korea University Guro Hospital
Study Overview
Official Title:
Korea University Guro Hospital
Status:
COMPLETED
Status Verified Date:
2009-11
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:
ELDER
Brief Summary:
Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure SBP in Korean ISH patients aged 60 to 80 years
Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure DBP in Korean ISH patients aged 60 to 80 years
To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation
Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure DBP in Korean ISH patients aged 60 to 80 years
To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation
Detailed Description:
Patients will receive lacidipine 4mg and amlodipine 5mg for initial 4 weeks If SBP is less than 140mmHg at Week 4 subjects continue to take lacidipine 4mg and amlodipine 5mg
If SBP is 140mmHg at Week 4 the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg
If BP is not controlled under 140mmHg at Week 8 diuretics will be added For 12 weeks of treatment period subjects will be visit to clinic at every 4 weeks
If SBP is 140mmHg at Week 4 the dose of lacidipine will be increased to 6mg and amlodipine will be increased to 10mg
If BP is not controlled under 140mmHg at Week 8 diuretics will be added For 12 weeks of treatment period subjects will be visit to clinic at every 4 weeks
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