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The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
generic formulation of atorvastatin (Atorva®)
branded formulation of atorvastatin (Lipitor®)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Atorva, generic, atorvastatin, hypercholesterolemia

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atorva

Lipitor

Arm Description

generic formulation (Atorva®) of atorvastatin 20mg once daily

branded formulation (Lipitor®) of atorvastatin 20mg once daily

Outcomes

Primary Outcome Measures

% change of LDL cholesterol
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])
% 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
LDL cholesterol goal achievement rate according to NECP-ATP III guideline

Full Information

First Posted
June 18, 2012
Last Updated
December 15, 2013
Sponsor
Seoul National University Hospital
Collaborators
Yuhan corp., Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01624207
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Yuhan corp., Seoul, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Atorva, generic, atorvastatin, hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorva
Arm Type
Experimental
Arm Description
generic formulation (Atorva®) of atorvastatin 20mg once daily
Arm Title
Lipitor
Arm Type
Active Comparator
Arm Description
branded formulation (Lipitor®) of atorvastatin 20mg once daily
Intervention Type
Drug
Intervention Name(s)
generic formulation of atorvastatin (Atorva®)
Intervention Description
Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
branded formulation of atorvastatin (Lipitor®)
Intervention Description
Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
Primary Outcome Measure Information:
Title
% change of LDL cholesterol
Description
The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group
Time Frame
After 8 weeks of treatment
Secondary Outcome Measure Information:
Title
% 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
Title
% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)
Time Frame
After 8 weeks of treatment
Title
Change of highly sensitive C-reactive protein (hsCRP)
Time Frame
After 8 weeks of treatment
Title
LDL cholesterol goal achievement rate
Description
LDL cholesterol goal achievement rate according to NECP-ATP III guideline
Time Frame
After 8 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

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