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

Phase 4

Completed

• Conditions: Cardiovascular Disease; Hypercholesterolemia; Dyslipidemia
• Interventions: Drug: Atorvastatin (Lipinon); Drug: Atorvastatin (Lipitor)

• Registration Number: NCT01285544
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-01-09
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-28
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipinon-test formulation of atrovastain - 20mg	Atorvastatin (Lipinon)	-
Lipitor- branded formuation of atorvastatin-20mg	Atorvastatin (Lipitor)	-

Primary Outcome Measures

Name	Time	Method
the percent change of LDL-C level	After taken medication for 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of