| Registry | NCT03648788 |
|---|
| Status | Unknown |
|---|
| Study type | Observational |
|---|
| Enrollment | 600 (Estimated) |
|---|
| Sponsor | IlDong Pharmaceutical Co Ltd (Industry) |
|---|
| Conditions | Mixed Dyslipidemia |
|---|
| Interventions | NA (Observation study) (Other) |
|---|
| Dates | start 2018-09-01 (estimated), primary completion 2024-06-01 (estimated), completion 2024-08-01 (estimated), first posted 2018-08-27, last updated 2018-09-06 |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Mixed Dyslipidemia All trials of NA (Observation study)
-Summary
Post-marketing surveillance of Rosuvastatin/Ezetimibe
Expand all sections · Collapse all
+Detailed description
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.
+Arms and interventions
- NA (Observation study) (Other): NA (Observation study)
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All
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