Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:59 AM
Study NCT ID:
NCT04774406
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2021-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.
The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
Detailed Description:
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: