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Trial record 69 of 333 for:    DABIGATRAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02240654
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : October 16, 2017
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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).

Condition or disease
Atrial Fibrillation

Detailed Description:
Study Design:

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Study Type : Observational
Actual Enrollment : 36573 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Dabigatran etexilate

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New users of dabigatran etexilate in each database

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02240654

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1160.144.1 Boehringer Ingelheim Investigational Site
Barcelona, Spain
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim Identifier: NCT02240654     History of Changes
Other Study ID Numbers: 1160.144
First Posted: September 16, 2014    Key Record Dates
Results First Posted: October 16, 2017
Last Update Posted: December 15, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action