The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: generic formulation of atorvastatin (Atorva®) (Drug); branded formulation of atorvastatin (Lipitor®) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Seoul National University Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: % change of LDL cholesterol
Secondary outcome: % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1])% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) Change of highly sensitive C-reactive protein (hsCRP) LDL cholesterol goal achievement rate
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
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 â…¢ (NCEP-ATP â…¢) 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.
Locations and Contacts
Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: March 2010
Last updated: December 15, 2013
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