Clinical trial NCT01624207: The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg
Official title: A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Atorva
generic
atorvastatin
hypercholesterolemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Yuhan corp., Seoul, Korea
First posted: 2012-06-20
Enrollment: 376
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: The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were men or women aged between 20 and 79 years who have not achieved LDL cholesterol goals using the National Cholesterol Education Program Adult Treatment Panel Ⅲ (NCEP-ATP Ⅲ) guideline, with the treatment goal of LDL cholesterol being \<100 mg/dL for patients with coronary artery disease (CAD) or CAD-equivalent disease, \<130 mg/dL for patients with multiple risk factors (10-year coronary heart disease \[CHD\] risk ≤20%), and \<160 mg/dL for patients with 0 to 1 risk factors.

Exclusion Criteria:

* Exclusion criteria were as follows: currently taking any kind of anti-hyperlipidemic drug (within 4 weeks before enrollment); hypersensitivity or intolerance to atorvastatin or other HMG-CoA reductase inhibitor; newly diagnosed (within 3 months before enrollment) or uncontrolled diabetes (hemoglobin A1C \>9%); uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels ≥2 times the upper limit of normal \[ULN\]); an unexplained serum creatinine kinase (CK) elevation \>2 times the ULN, chronic renal failure (a serum creatinine concentration \>2.5 mg/dL); in patients who experienced operation at the time of screening, the patients must have a result of lipid profiles within 24 hours or after 6 weeks; a history of malignancy or cervical dysplasia; pregnant or breastfeeding women; women of childbearing potential had to be using adequate methods of contraception; a history of drug abuse or alcoholism; participation in other studies 4 weeks before enrollment. Patients could also be excluded if their participation was considered inappropriate by the study physician.

Primary outcomes:
measure: % change of LDL cholesterol
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1])
timeFrame: After 8 weeks of treatment
measure: % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)
timeFrame: After 8 weeks of treatment
measure: Change of highly sensitive C-reactive protein (hsCRP)
timeFrame: After 8 weeks of treatment
measure: LDL cholesterol goal achievement rate
timeFrame: After 8 weeks of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: