The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborator:
Yuhan corp., Seoul, Korea
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01624207
First received: June 18, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: generic formulation of atorvastatin (Atorva®) Drug: branded formulation of atorvastatin (Lipitor®) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- % change of LDL cholesterol [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group
Secondary Outcome Measures:
- % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1]) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
- % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
- Change of highly sensitive C-reactive protein (hsCRP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
- LDL cholesterol goal achievement rate [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]LDL cholesterol goal achievement rate according to NECP-ATP III guideline
| Enrollment: | 376 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Atorva
generic formulation (Atorva®) of atorvastatin 20mg once daily
|
Drug: generic formulation of atorvastatin (Atorva®)
Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
|
|
Active Comparator: Lipitor
branded formulation (Lipitor®) of atorvastatin 20mg once daily
|
Drug: branded formulation of atorvastatin (Lipitor®)
Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01624207 History of Changes |
| Other Study ID Numbers: | ROYAL, H-1002-038-309 |
| Study First Received: | June 18, 2012 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
|
Atorva generic atorvastatin hypercholesterolemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013