NCT00460915

Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years

Korea University Guro Hospital

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Lacidipine & Amlodipine

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-07-01
• Completion: 2010-02-01
• First posted: 2007-04-17
• Last updated: 2010-03-02

Locations

1 site across 1 country: South Korea