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

Primary Purpose

Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin (Lipinon)
Atorvastatin (Lipitor)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lipinon-test formulation of atrovastain - 20mg

Lipitor- branded formuation of atorvastatin-20mg

Arm Description

Outcomes

Primary Outcome Measures

the percent change of LDL-C level

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)

Full Information

First Posted
January 9, 2011
Last Updated
December 15, 2013
Sponsor
Seoul National University Hospital
Collaborators
Dong-A Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01285544
Brief Title
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Dong-A Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia
Keywords
statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipinon-test formulation of atrovastain - 20mg
Arm Type
Experimental
Arm Title
Lipitor- branded formuation of atorvastatin-20mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin (Lipinon)
Intervention Description
treatment of dyslipidemia administration : PO, qod
Intervention Type
Drug
Intervention Name(s)
Atorvastatin (Lipitor)
Intervention Description
treatment of dyslipidemia administration : PO, qod
Primary Outcome Measure Information:
Title
the percent change of LDL-C level
Time Frame
After taken medication for 8 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23274145
Citation
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.
Results Reference
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The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia

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