Last reviewed · How we verify
A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.
Details
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 376 |
| Start date | 2010-03 |
| Completion | 2011-04 |
Conditions
- Hypercholesterolemia
Interventions
- generic formulation of atorvastatin (Atorva®)
- branded formulation of atorvastatin (Lipitor®)
Primary outcomes
- % change of LDL cholesterol — After 8 weeks of treatment
The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group
Countries
South Korea