Efficacy and Safety of Pitavastatin in a Real-world Setting

NCT ID: NCT04402112

Last Updated: 2021-04-19

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

Total Enrollment

28343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-02

Study Completion Date

2017-08-01

Brief Summary

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The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.

Detailed Description

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This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.

Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pitavastatin

1mg, 2mg, or 4mg, Once a day, at least 8 weeks

Intervention Type DRUG

Other Intervention Names

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LIVALO

Eligibility Criteria

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Inclusion Criteria

* Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.

Exclusion Criteria

* Patients with hypersensitivity to pitavastatin
* Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
* Patients with severe liver failure or biliary obstruction and patients with cholestasis
* Patients who are receiving cyclosporine
* Myopathy patients
* Pregnant women or women of childbearing age and lactating women
* Children
* Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
* Patients deemed inappropriate by the investigator
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung-Rae Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

References

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Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.

Reference Type RESULT
PMID: 33261312 (View on PubMed)

Other Identifiers

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JWP-PTV-712

Identifier Type: -

Identifier Source: org_study_id

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