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
  Purpose

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 Intervention Phase
Dyslipidemia
Cardiovascular Disease
Hypercholesterolemia
Drug: Atorvastatin (Lipinon)
Drug: 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: Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the percent change of LDL-C level [ Time Frame: After taken medication for 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 289
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01285544

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Dong-A Parmaceutical
  More Information

No publications provided by Seoul National University Hospital

Additional 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
Study First Received: January 9, 2011
Last Updated: December 15, 2013
Health Authority: South Korea: Institutional Review Board

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
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 21, 2014