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NCT06314919 Clinical Trial

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

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06314919
Other study ID # BR-PEC-OS-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2024
Est. completion date March 2026

Study information
Verified date April 2024
Source Boryung Pharmaceutical Co., Ltd
Contact Shin-young Oh
Phone +82-2-708-8000
Email syoh@boryung.co.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 8606
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Ewha Womans University Seoul Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of reaching the target LDL Cholesterol level 12 weeks after administration
See also
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