Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

NCT ID: NCT04511000

Last Updated: 2020-08-12

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2019-05-20

Brief Summary

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This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

Detailed Description

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Conditions

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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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Experimental group

Group Type EXPERIMENTAL

Lipilou®(generic atorvastatin drug) 20 mg

Intervention Type DRUG

Patients assigned to experimental group are treated with Lipilou® 20 mg

Comparator group

Group Type ACTIVE_COMPARATOR

Lipilou®(generic atorvastatin drug) 10 mg

Intervention Type DRUG

Patients assigned to comparator group are treated with Lipilou® 10 mg

Interventions

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Lipilou®(generic atorvastatin drug) 20 mg

Patients assigned to experimental group are treated with Lipilou® 20 mg

Intervention Type DRUG

Lipilou®(generic atorvastatin drug) 10 mg

Patients assigned to comparator group are treated with Lipilou® 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.

Exclusion Criteria

* Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
* Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Ansan Hospital

Ansan, , South Korea

Site Status

Sejong General Hospital

Bucheon-si, , South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Myongji Hospital

Goyang, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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124HL17003

Identifier Type: -

Identifier Source: org_study_id

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