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

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

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

20 mg

Other names: Lipinon

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Mar 5, 2010
Registry last updated: Mar 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed