Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia

This study has been completed.
Sponsor:
Collaborator:
Dong-A Parmaceutical
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01285544
First received: January 9, 2011
Last updated: December 15, 2013
Last verified: December 2013

January 9, 2011
December 15, 2013
September 2008
July 2009   (final data collection date for primary outcome measure)
the percent change of LDL-C level [ Time Frame: After taken medication for 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01285544 on ClinicalTrials.gov Archive Site
the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP) [ Time Frame: After taken medication for 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial

There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dyslipidemia
  • Cardiovascular Disease
  • Hypercholesterolemia
  • Drug: Atorvastatin (Lipinon)
    treatment of dyslipidemia administration : PO, qod
  • Drug: Atorvastatin (Lipitor)
    treatment of dyslipidemia administration : PO, qod
  • Experimental: Lipinon-test formulation of atrovastain - 20mg
    Intervention: Drug: Atorvastatin (Lipinon)
  • Active Comparator: Lipitor- branded formuation of atorvastatin-20mg
    Intervention: Drug: Atorvastatin (Lipitor)
Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
  • Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes

Exclusion Criteria:

  • therapy with any other investigational drug within 30 days of randomization,
  • history of hypersensitivity to HMG-CoA reductase inhibitors,
  • uncontrolled hypertension,
  • poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),
  • unstable angina or presented with new-onset myocardial infarction (within 6 months),
  • creatinine >2.5 mg/dl,
  • alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN,
  • history of malignancy or psychosis;
  • chronic liver disease,
  • drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01285544
Lipinon Study, H-0807-056-251
Yes
Not Provided
Seoul National University Hospital
Dong-A Parmaceutical
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