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

This study has been completed.
Sponsor:
Collaborator:
Yuhan corp., Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01624207
First received: June 18, 2012
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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
Hypercholesterolemia
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

  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01624207

Locations
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
ClinicalTrials.gov 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:
Atorva
generic
atorvastatin
hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014