Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
NCT ID: NCT02240654
Last Updated: 2017-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
36573 participants
OBSERVATIONAL
2014-11-28
2016-05-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants
NCT03742336
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
NCT00558259
Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa
NCT02149303
Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers
NCT02171559
Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..
NCT04297150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dabigatran etexilate
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1160.144.1 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-723. doi: 10.1002/pds.4416. Epub 2018 Mar 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1160.144
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.