Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

NCT ID: NCT05279833

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-24

Study Completion Date

2022-03-31

Brief Summary

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A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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dronedarone

Pharmaceutical form is tablet and route of administration is oral

Intervention Type DRUG

sotalol

Pharmaceutical form is tablet and route of administration is oral

Intervention Type DRUG

Other Intervention Names

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Multaq® BETAPACE®

Eligibility Criteria

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Inclusion Criteria

Following eligibility criteria are defined to select relevant studies from the literature

* Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \[over 12 months\]))
* Participants have received either Dronedarone or Sotalol
* controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies

Exclusion Criteria

* Children/adolescents
* Permanent atrial fibrillation (AFib)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences and Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis, France

Chilly-Mazarin, , France

Site Status

Countries

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France

References

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Singh JP, Blomstrom-Lundqvist C, Turakhia MP, Camm AJ, Fazeli MS, Kreidieh B, Crotty C, Kowey PR. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023 Jun;46(6):589-597. doi: 10.1002/clc.24011. Epub 2023 Apr 6.

Reference Type RESULT
PMID: 37025083 (View on PubMed)

Other Identifiers

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CSA0010

Identifier Type: -

Identifier Source: org_study_id

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