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

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

Recruiting

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Key information

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ewha Womans University Seoul Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

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

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Rate of reaching the target LDL Cholesterol level

Time frame: 12 weeks after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Shin-young Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 18, 2024
Registry last updated: Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed