Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862962
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-04-23
Brief Title:
Study to Evaluate the Safety of the Fixed-dose Combination RosuvastatinEzetimibe for Patients With Dyslipidaemia
Sponsor:
Laboratorios Silanes SA de CV
Organization:
Laboratorios Silanes SA de CV
Study Overview
Official Title:
Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREZETE
Brief Summary:
Retrospective analytical longitudinal multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin ezetimibe as treatment for patients with dyslipidemia in routine medical practice
Detailed Description:
To assess the safety of the fixed-dose combination of rosuvastatin ezetimibe in subjects older than 18 years of age gender indistinct with dyslipidemia who at the discretion have been candidates for treatment with the combination For the safety analysis all the research subjects who have taken rosuvastatin ezetimibe will be considered The information recorded by the treating physicians in the file will be reviewed and within the case report format CRF of all adverse events that occur in the study The terms originally used in the case report format by the investigators to identify adverse events AE will be coded in the analysis stage of Results using the current MEdDRA dictionary The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None