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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01285544

Enrollment

289

Registered

2011-01-28

Start date

2008-09-30

Completion date

2009-07-31

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Dyslipidemia, Hypercholesterolemia

Keywords

statins, cholesterol, hypercholesterolemia, atorvastatin, Dyslipidemia in cardiovascular disease (KoLipinon)

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.

Interventions

DRUGAtorvastatin (Lipinon)

treatment of dyslipidemia administration : PO, qod

DRUGAtorvastatin (Lipitor)

treatment of dyslipidemia administration : PO, qod

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame
the percent change of LDL-C level	After taken medication for 8 weeks

Secondary

Measure	Time frame
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)	After taken medication for 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026