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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Dong-A Parmaceutical; Dong-A Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium

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.