A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia

NCT ID: NCT01081548

Last Updated: 2010-03-05

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Generic

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

20 mg

Lipitor

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

20 mg

Interventions

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atorvastatin

20 mg

Intervention Type DRUG

atorvastatin

20 mg

Intervention Type DRUG

Other Intervention Names

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Lipinon Lipitor

Eligibility Criteria

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Inclusion Criteria

* Age 20 \~ 79
* People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
* In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Dept of Cardiology/Severance Hospital/Yonsei U

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2008-0288

Identifier Type: -

Identifier Source: org_study_id

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