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

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: branded formulation of atorvastatin (Lipitor®); Drug: generic formulation of atorvastatin (Atorva®)

• Registration Number: NCT01624207
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-04
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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.

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Exclusion Criteria

• Exclusion criteria were as follows: currently taking any kind of anti-hyperlipidemic drug (within 4 weeks before enrollment); hypersensitivity or intolerance to atorvastatin or other HMG-CoA reductase inhibitor; newly diagnosed (within 3 months before enrollment) or uncontrolled diabetes (hemoglobin A1C >9%); uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels ≥2 times the upper limit of normal [ULN]); an unexplained serum creatinine kinase (CK) elevation >2 times the ULN, chronic renal failure (a serum creatinine concentration >2.5 mg/dL); in patients who experienced operation at the time of screening, the patients must have a result of lipid profiles within 24 hours or after 6 weeks; a history of malignancy or cervical dysplasia; pregnant or breastfeeding women; women of childbearing potential had to be using adequate methods of contraception; a history of drug abuse or alcoholism; participation in other studies 4 weeks before enrollment. Patients could also be excluded if their participation was considered inappropriate by the study physician.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipitor	branded formulation of atorvastatin (Lipitor®)	branded formulation (Lipitor®) of atorvastatin 20mg once daily
Atorva	generic formulation of atorvastatin (Atorva®)	generic formulation (Atorva®) of atorvastatin 20mg once daily

Primary Outcome Measures

Name	Time	Method
% 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 Outcome Measures

Name	Time	Method
% 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 highly sensitive C-reactive protein (hsCRP)	After 8 weeks of treatment
% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of