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

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ClinicalTrials.gov Identifier: NCT01285544
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
Dong-A Pharmaceutical
Information provided by:
Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Cardiovascular Disease Hypercholesterolemia Drug: Atorvastatin (Lipinon) Drug: Atorvastatin (Lipitor) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009


Arm Intervention/treatment
Experimental: Lipinon-test formulation of atrovastain - 20mg Drug: Atorvastatin (Lipinon)
treatment of dyslipidemia administration : PO, qod
Active Comparator: Lipitor- branded formuation of atorvastatin-20mg Drug: Atorvastatin (Lipitor)
treatment of dyslipidemia administration : PO, qod



Primary Outcome Measures :
  1. the percent change of LDL-C level [ Time Frame: After taken medication for 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285544


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Dong-A Pharmaceutical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01285544     History of Changes
Other Study ID Numbers: Lipinon Study
H-0807-056-251
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Seoul National University Hospital:
statins
cholesterol
hypercholesterolemia
atorvastatin
Dyslipidemia in cardiovascular disease (KoLipinon)

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