Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Essential Hypertension
• Interventions: Drug: Lacidipine

• Registration Number: NCT00328965
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean population.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-12
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacidipine	Lacidipine	All subjects who meet eligiblity criteria receive 2mg for the first 4 weeks in an open manner. If target systolic blood pressure is not ahcieved, subject can increase the dose to 4mg and then 6mg consequently.

Primary Outcome Measures

Name	Time	Method
To investigate the clinical effectiveness of lacidipine on elevated systolic blood pressure (SBP) in Korean patients aged 35 to 75 years.	12 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
To investigate the clinical effectiveness of lacidipine on elevated diastolic blood pressure and endothelial function by flow-medicated vasodilation and measurement of markers of inflammation in Korean patients aged 35 to 75 years with type 2 diabetes.	12 weeks from baseline