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

Mixed Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03648788
• Other study ID #: ID-DRT-401
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: August 2024

Study information

• Verified date: August 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Sujin Kim
• Phone: 82-2-526-3478
• Email: sujinkim[@]ildong.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-marketing surveillance of Rosuvastatin/Ezetimibe

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Mixed Dyslipidemia

Intervention

Other:
• NA (Observation study)
NA (Observation study)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse event after this drug administration in general medical practice	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.	24 weeks
Primary	Incidence of serious adverse event after this drug administration in general medical practice	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.	24 weeks