Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dyslipidemias
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04862962
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joel Rodriguez Saldaña, M.D Resultados Médicos, desarrollo e Investigación Principal Investigator: Francisco G Padilla Padilla, M.D Independent Principal Investigator: Ernesto G Cardona Muñoz, M.D Independent Principal Investigator: David Cardona Müller, M.D Independent Principal Investigator: Marcos Ibarra Flores, M.D Cardiólogos Certificados S.C Principal Investigator: José A Estrada Suarez, M.D Independent