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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06314919

Enrollment

8606

Registered

2024-03-18

Start date

2024-03-15

Completion date

2026-06-30

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Dyslipidemia, Primary Hypercholesterolemia

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of reaching the target LDL Cholesterol level	12 weeks after administration

Countries

South Korea

Contacts

Primary ContactShin-young Oh

syoh@boryung.co.kr+82-2-708-8000

Outcome results