A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe

• Conditions: Mixed Dyslipidemia

• Registration Number: NCT03648788
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

Post-marketing surveillance of Rosuvastatin/Ezetimibe

Detailed Description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• The patient who is first prescribed and administered Rosuvastatin/Ezetimibe

Exclusion Criteria

• The patients who are overreacting to this drug or its components
• The patients with severe renal impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse event after this drug administration in general medical practice	24 weeks	Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.; Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
Incidence of serious adverse event after this drug administration in general medical practice	24 weeks	Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.; Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.