The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01624207

Enrollment

376

Registered

2012-06-20

Start date

2010-03-31

Completion date

2011-04-30

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Atorva, generic, atorvastatin, hypercholesterolemia

Brief summary

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.

Interventions

DRUGgeneric formulation of atorvastatin (Atorva®)

Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks

DRUGbranded formulation of atorvastatin (Lipitor®)

Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Eligible patients were men or women aged between 20 and 79 years who have not achieved LDL cholesterol goals using the National Cholesterol Education Program Adult Treatment Panel Ⅲ (NCEP-ATP Ⅲ) guideline, with the treatment goal of LDL cholesterol being \<100 mg/dL for patients with coronary artery disease (CAD) or CAD-equivalent disease, \<130 mg/dL for patients with multiple risk factors (10-year coronary heart disease \[CHD\] risk ≤20%), and \<160 mg/dL for patients with 0 to 1 risk factors.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
% 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

Secondary

Measure	Time frame	Description
% change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1])	After 8 weeks of treatment	—
% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)	After 8 weeks of treatment	—
Change of highly sensitive C-reactive protein (hsCRP)	After 8 weeks of treatment	—
LDL cholesterol goal achievement rate	After 8 weeks of treatment	LDL cholesterol goal achievement rate according to NECP-ATP III guideline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026