Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
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|ClinicalTrials.gov Identifier: NCT02240654|
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : October 16, 2017
Last Update Posted : December 15, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||36573 participants|
|Official Title:||Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe|
|Actual Study Start Date :||November 28, 2014|
|Actual Primary Completion Date :||May 20, 2016|
|Actual Study Completion Date :||May 20, 2016|
- Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. [ Time Frame: 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. ]
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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240654
|1160.144.1 Boehringer Ingelheim Investigational Site|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|