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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01081548

4-2008-0288

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

17 participants in 2 patient groups

Generic

Experimental group

Treatment:

Drug: atorvastatin

Drug: atorvastatin

Lipitor

Active Comparator group

Treatment:

Drug: atorvastatin

Drug: atorvastatin