A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

NCT ID: NCT06314919

Last Updated: 2025-09-12

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

RECRUITING

Total Enrollment

8606 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition

Detailed Description

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Conditions

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Primary Hypercholesterolemia Mixed Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
* Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe

Exclusion Criteria

* Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
* Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
* Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ewha Womans University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shin-young Oh

Role: CONTACT

+82-2-708-8000

Facility Contacts

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Wook-Bum Pyun, M.D., Ph.D.

Role: primary

Other Identifiers

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BR-PEC-OS-401

Identifier Type: -

Identifier Source: org_study_id

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