Arterial Hypertension Related to PARP Inhibitors (ArteRIB) | NCT04774406

Studies
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

NCT04774406

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jun 6, 2023Actual

Enrollment

2,336Actual

Phase

Not provided

Conditions

Cancer

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2021Actual

Primary Completion Date

May 9, 2021Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2023

Last Update Posted Date

Jun 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parp inhibitors		All patients treated at least with 1 PARPi	Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib	Drug	All patients treated at least with 1 PARPi (alone or in combination)	parp inhibitors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cancer patients treated with PARPi and experiencing hypertension.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandre Joachim		Caen	Basse Normandie	14000	France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531550	olaparib
C531549	rucaparib
C545685	niraparib
C586365	talazoparib
C521013	veliparib
C000707927	pamiparib
C000722917	fluzoparib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided