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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01081548
First received: March 4, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

March 4, 2010
March 4, 2010
August 2008
July 2009   (final data collection date for primary outcome measure)
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No Changes Posted
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A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia
A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hypercholesterolemia
  • Drug: atorvastatin
    20 mg
    Other Name: Lipinon
  • Drug: atorvastatin
    20 mg
    Other Name: Lipitor
  • Experimental: Generic
    Intervention: Drug: atorvastatin
  • Active Comparator: Lipitor
    Intervention: Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01081548
4-2008-0288
Not Provided
Dong Hoon Choi/Prof., Dept of Cardiology/Severance Hospital/Yonsei U
Yonsei University
Not Provided
Not Provided
Yonsei University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP