Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years (ELDER)
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|ClinicalTrials.gov Identifier: NCT00460915|
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : March 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Lacidipine & Amlodipine||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Korea University Guro Hospital|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||February 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460915
|Korea, Republic of|
|Korea University Guro Hospital|
|Seoul, Korea, Republic of, 152-703|
|Principal Investigator:||Hong-seog Seo||Korea University Guro Hospital|