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

Tracking Information
First Received Date ^ICMJE	March 4, 2010
Last Updated Date	March 4, 2010
Start Date ^ICMJE	August 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia
Official Title ^ICMJE	A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
Brief Summary	The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Drug: atorvastatin 20 mg Other Name: Lipinon Drug: atorvastatin 20 mg Other Name: Lipitor
Study Arm (s)	Experimental: Generic Intervention: Drug: atorvastatin Active Comparator: Lipitor Intervention: Drug: atorvastatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	17
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01081548
Other Study ID Numbers ^ICMJE	4-2008-0288
Has Data Monitoring Committee	Not Provided
Responsible Party	Dong Hoon Choi/Prof., Dept of Cardiology/Severance Hospital/Yonsei U
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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