Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Atrial Fibrillation Clinical Trial

Official title:

Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240654
• Other study ID #: 1160.144
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: November 6, 2017
• Start date: November 28, 2014
• Est. completion date: May 20, 2016

Study information

• Verified date: November 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Description:

Study Design:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36573
• Est. completion date: May 20, 2016
• Est. primary completion date: May 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

1. Have at least 1 year of enrolment in the electronic database.

2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Spain	1160.144.1 Boehringer Ingelheim Investigational Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.	Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.; Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.; SPAF:Stroke & systemic embolism in adult patients with non-valvular AF	Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.

External Links

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