Status:
COMPLETED
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation and Flutter
Eligibility:
MALE
18+ years
Brief Summary
Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis. CYP17A inhi...
Detailed Description
Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics o...
Eligibility Criteria
Inclusion
- Case reported in the French pharmacovigilance database from 01/01/1985 to 16/05/2017
- Case reported in the EudraCT database to May 2017
- Adverse event reported were including the MedDRA terms: SOC Cardiac Disorders; SOC Vascular Disorders; HLT Death, Sudden Death; HLGT Water, electrolyte and mineral investigations; HLGT Cardiac and vascular investigations (excl enzyme tests); and PT Syncope.
- Patients treated with hormonal therapies included in the ATC L02, and G03
Exclusion
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
May 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
1717 Patients enrolled
Trial Details
Trial ID
NCT03243604
Start Date
May 16 2017
End Date
July 13 2017
Last Update
October 18 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière
Paris, Île-de-France Region, France, 75013