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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

June 18, 2012
December 15, 2013
March 2010
January 2011   (final data collection date for primary outcome measure)
% 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
Same as current
Complete list of historical versions of study NCT01624207 on ClinicalTrials.gov Archive Site
  • % 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: generic formulation of atorvastatin (Atorva®)
    Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
  • Drug: branded formulation of atorvastatin (Lipitor®)
    Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
  • Experimental: Atorva
    generic formulation (Atorva®) of atorvastatin 20mg once daily
    Intervention: Drug: generic formulation of atorvastatin (Atorva®)
  • Active Comparator: Lipitor
    branded formulation (Lipitor®) of atorvastatin 20mg once daily
    Intervention: Drug: branded formulation of atorvastatin (Lipitor®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
April 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01624207
ROYAL, H-1002-038-309
Yes
Seoul National University Hospital
Seoul National University Hospital
Yuhan corp., Seoul, Korea
Not Provided
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP