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NCT04774406 Clinical Trial

Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Cancer Clinical Trial

Official title:
Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04774406
Other study ID # Pharmaco 16022023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2021
Est. completion date September 1, 2022

Study information
Verified date May 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2336
Est. completion date September 1, 2022
Est. primary completion date May 9, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, - patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none). Exclusion Criteria: -chronology not compatible between the PARPi and adverse event

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
All patients treated at least with 1 PARPi (alone or in combination)

Locations
Country Name City State
France Alexandre Joachim Caen Basse Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary hypertension reports related to PARPi. Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports. From inception to 16 Feb, 2023
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