Clinical trial NCT01285544: The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Cardiovascular Disease
Hypercholesterolemia
Keywords: statins
cholesterol
hypercholesterolemia
atorvastatin
Dyslipidemia in cardiovascular disease (KoLipinon)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical
First posted: 2011-01-28
Enrollment: 289
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: the percent change of LDL-C level
timeFrame: After taken medication for 8 weeks
Secondary outcomes:
measure: 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)
timeFrame: After taken medication for 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28.