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Completed

NCT Number: NCT04774406

Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre Joachim

Caen, Basse Normandie, 14000, France

About this study

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib

Drug

All patients treated at least with 1 PARPi (alone or in combination)

Primary outcomes

  1. hypertension reports related to PARPi.

    Time frame: From inception to 16 Feb, 2023

    Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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