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

Cardiovascular Disease Clinical Trial

Official title:

Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285544
• Other study ID #: Lipinon Study
• Secondary ID: H-0807-056-251
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2011
• Last updated: December 15, 2013
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin (Lipinon)
treatment of dyslipidemia administration : PO, qod
• Atorvastatin (Lipitor)
treatment of dyslipidemia administration : PO, qod

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A Parmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent change of LDL-C level		After taken medication for 8 weeks	No
Secondary	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	No