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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Dyslipidemia

Cardiovascular Disease

Treatments

Drug: Atorvastatin (Lipitor)

Drug: Atorvastatin (Lipinon)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01285544

H-0807-056-251

Lipinon Study

Details and patient eligibility

About

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.

Enrollment

289 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No 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.