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

NCT ID: NCT01624207

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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Atorva generic atorvastatin hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorva

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

Group Type EXPERIMENTAL

generic formulation of atorvastatin (Atorva®)

Intervention Type DRUG

Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks

Lipitor

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

Group Type ACTIVE_COMPARATOR

branded formulation of atorvastatin (Lipitor®)

Intervention Type DRUG

Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

Interventions

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generic formulation of atorvastatin (Atorva®)

Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks

Intervention Type DRUG

branded formulation of atorvastatin (Lipitor®)

Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan corp., Seoul, Korea

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1002-038-309

Identifier Type: OTHER

Identifier Source: secondary_id

ROYAL

Identifier Type: -

Identifier Source: org_study_id