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

NCT01624207 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2013-12-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

generic formulation of atorvastatin (Atorva®)

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

DRUG

branded formulation of atorvastatin (Lipitor®)

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

Sponsors & Collaborators

  • Yuhan corp., Seoul, Korea

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-01-31
Completion
2011-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624207 on ClinicalTrials.gov