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

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia

Intervention: atorvastatin (Drug); atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Yonsei University

Summary

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

Clinical Details

Official title: A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of LipinonŽ 20mg Versus LipitorŽ 20mg in Korean Patients With Hypercholesterolemia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Severance Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: August 2008
Last updated: March 4, 2010

Page last updated: August 23, 2015

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