Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

June 5, 2023 updated by: University Hospital, Caen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • Alexandre Joachim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Cancer patients treated with PARPi and experiencing hypertension.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
parp inhibitors
All patients treated at least with 1 PARPi
Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
All patients treated at least with 1 PARPi (alone or in combination)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From inception to 16 Feb, 2023

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of the latency period since first PARPi exposure
Time Frame: From inception to March, 2021
From inception to March, 2021
Description of patients who experienced co-reported adverse events
Time Frame: From inception to March, 2021
From inception to March, 2021
Description of the fatality rate
Time Frame: From inception to March, 2021
From inception to March, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Actual)

May 9, 2021

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmaco 16022023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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