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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: generic formulation of atorvastatin (Atorva®); Drug: branded formulation of atorvastatin (Lipitor®)

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorva; generic formulation (Atorva®) of atorvastatin 20mg once daily	Drug: generic formulation of atorvastatin (Atorva®); Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
Active Comparator: Lipitor; branded formulation (Lipitor®) of atorvastatin 20mg once daily	Drug: branded formulation of atorvastatin (Lipitor®); Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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	LDL cholesterol goal achievement rate according to NECP-ATP III guideline	After 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Yuhan corp., Seoul, Korea

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 15, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: hypercholesterolemia; atorvastatin; generic; Atorva
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: ROYAL; H-1002-038-309 (Other Identifier: Seoul National University Hospital)