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

NCT ID: NCT01285544

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia Cardiovascular Disease Hypercholesterolemia

Keywords

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statins cholesterol hypercholesterolemia atorvastatin Dyslipidemia in cardiovascular disease (KoLipinon)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lipinon-test formulation of atrovastain - 20mg

Group Type EXPERIMENTAL

Atorvastatin (Lipinon)

Intervention Type DRUG

treatment of dyslipidemia administration : PO, qod

Lipitor- branded formuation of atorvastatin-20mg

Group Type ACTIVE_COMPARATOR

Atorvastatin (Lipitor)

Intervention Type DRUG

treatment of dyslipidemia administration : PO, qod

Interventions

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Atorvastatin (Lipinon)

treatment of dyslipidemia administration : PO, qod

Intervention Type DRUG

Atorvastatin (Lipitor)

treatment of dyslipidemia administration : PO, qod

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 23274145 (View on PubMed)

Other Identifiers

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H-0807-056-251

Identifier Type: -

Identifier Source: secondary_id

Lipinon Study

Identifier Type: -

Identifier Source: org_study_id