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

This study has been completed.
Yuhan corp., Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital Identifier:
First received: June 18, 2012
Last updated: December 15, 2013
Last verified: December 2013

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.

Condition Intervention Phase
Drug: generic formulation of atorvastatin (Atorva®)
Drug: branded formulation of atorvastatin (Lipitor®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • % change of LDL cholesterol [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group

Secondary Outcome Measures:
  • % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1]) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Change of highly sensitive C-reactive protein (hsCRP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • LDL cholesterol goal achievement rate [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    LDL cholesterol goal achievement rate according to NECP-ATP III guideline

Enrollment: 376
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01624207

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Yuhan corp., Seoul, Korea
  More Information

No publications provided

Responsible Party: Seoul National University Hospital Identifier: NCT01624207     History of Changes
Other Study ID Numbers: ROYAL, H-1002-038-309
Study First Received: June 18, 2012
Last Updated: December 15, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015