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
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