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
2 other identifiers
interventional
376
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedDecember 17, 2013
December 1, 2013
10 months
June 18, 2012
December 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% change of LDL cholesterol
The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group
After 8 weeks of treatment
Secondary Outcomes (4)
% 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
Study Arms (2)
Atorva
EXPERIMENTALgeneric formulation (Atorva®) of atorvastatin 20mg once daily
Lipitor
ACTIVE COMPARATORbranded formulation (Lipitor®) of atorvastatin 20mg once daily
Interventions
Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Yuhan corp., Seoul, Koreacollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
March 1, 2010
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
December 17, 2013
Record last verified: 2013-12