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

NCT03648788 | Unknown

• 1 other identifier: ID-DRT-401
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-marketing surveillance of Rosuvastatin/Ezetimibe

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

NA (Observation study) OTHER

NA (Observation study)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient diagnosed with mixed dyslipidemia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Sujin Kim

CONTACT

82-2-526-3478; sujinkim@ildong.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 27, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 6, 2018

Record last verified: 2018-08