Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years (ELDER)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Korea University Guro Hospital|
- Change from baseline in the mean SBP at week 12
- Change from baseline in the mean DBP at week 12
- Change from baseline in the CRP at week 12
|Study Start Date:||January 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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
|Korea, Republic of|
|Korea University Guro Hospital|
|Seoul, Korea, Republic of, 152-703|
|Principal Investigator:||Hong-seog Seo||Korea University Guro Hospital|