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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01081548
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : March 5, 2010
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: atorvastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official 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
Study Start Date : August 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Arms and Interventions

Arm Intervention/treatment
Experimental: Generic Drug: atorvastatin
20 mg
Other Name: Lipinon
Active Comparator: Lipitor Drug: atorvastatin
20 mg
Other Name: Lipitor

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081548

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party: Dong Hoon Choi/Prof., Dept of Cardiology/Severance Hospital/Yonsei U
ClinicalTrials.gov Identifier: NCT01081548     History of Changes
Other Study ID Numbers: 4-2008-0288
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors