A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: atorvastatin

• Registration Number: NCT01081548
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-01
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Last Update Submitted: 2010-03-04
• Study First Posted: 2010-03-05
• Last Update Posted: 2010-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Age 20 ~ 79
• People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
• In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Generic	atorvastatin	-
Lipitor	atorvastatin	-

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of