Clinical Trials

Numerous clinical trials evaluate dabigatran etexilate across Early Phase 1 through Phase 4, with recruitment statuses ranging from completed to actively recruiting and active non-recruiting. These studies assess indications including venous thromboembolism, atrial fibrillation, aortic valve stenosis, surgical hemorrhages, and interstitial lung diseases such as idiopathic pulmonary fibrosis, alongside pharmacokinetic evaluations in healthy volunteers. Sponsoring entities encompass major pharmaceutical corporations and leading academic research centers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06650501 RECRUITING
Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Septicemia; Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Bloodstream Infection; S. Aureus Bacteremia; S. Aureus Bloodstream Infection
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2026-01-15 PHASE4
NCT07744386 NOT_YET_RECRUITING
Healthy Male Volunteers
Chiesi Farmaceutici S.p.A.
 2026-10-27 PHASE1
NCT07746882 NOT_YET_RECRUITING
Stroke; Acute Ischemic Stroke
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-08-15 PHASE3
NCT06957366 RECRUITING
Atrial Fibrillation (AF); VTE
McMaster University
 2025-04-01
NCT03129490 ACTIVE_NOT_RECRUITING
Atrial Fibrillation; Atrial Flutter
Herlev and Gentofte Hospital
 2023-04-01 PHASE4
NCT05735639 RECRUITING
Venous Thromboembolism; Varicose Veins
Imperial College London
 2024-01-22 PHASE4
NCT07629999 RECRUITING
Healthy Volunteers
Bristol-Myers Squibb
 2026-07-13 PHASE1
NCT03129555 ACTIVE_NOT_RECRUITING
Deep Vein Thrombosis; Pulmonary Embolism
Herlev and Gentofte Hospital
 2023-04-01 PHASE4
NCT07744802 NOT_YET_RECRUITING
Healthy Male Participants
Deciphera Pharmaceuticals, LLC
 2026-09 PHASE1
NCT06551402 RECRUITING
Cerebral Venous Sinus Thrombosis
Kafrelsheikh University
 2024-08-09 PHASE3
NCT04045093 ACTIVE_NOT_RECRUITING
Atrial Fibrillation; Mitral Stenosis
The University of Hong Kong
 2020-10-22 PHASE4
NCT04695106 RECRUITING
Atrial Fibrillation; Antithrombotic Therapy; Acute Coronary Syndrome; Percutaneous Coronary Interventions
Medical University of Gdansk
 2021-10-25 PHASE4
NCT07515339 WITHDRAWN
Chronic Kidney Disease
Bayer
 2026-04-08 PHASE1
NCT06449469 ACTIVE_NOT_RECRUITING
Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Valve Disease, Aortic
Rigshospitalet, Denmark
 2021-05-01
NCT06818279 NOT_YET_RECRUITING
Portal Vein Thrombosis; Liver Cirrhosis
Institute of Liver and Biliary Sciences, India
 2025-01-31 PHASE2; PHASE3
NCT06273215 UNKNOWN
Diabetes
Peking University Third Hospital
 2023-03-05 PHASE4
NCT07190430 ACTIVE_NOT_RECRUITING
Atopic Dermatitis
Pfizer
 2025-10-03 PHASE1
NCT06945276 COMPLETED
COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)
 2025-05-13 PHASE1
NCT03568890 ACTIVE_NOT_RECRUITING
Left Atrial Appendage Closure; Thrombosis; Stroke; TIA; Bleeding
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
 2018-09-01 PHASE4
NCT06791187 COMPLETED
Healthy
Boehringer Ingelheim
 2025-01-23 PHASE1
NCT03961334 UNKNOWN
Stroke, Ischemic
University of Zurich
 2019-12-05 PHASE3
NCT06693518 COMPLETED
SARS-CoV-2 Infections
Pfizer
 2024-11-22 PHASE1
NCT06360055 UNKNOWN
Health
Peking University Third Hospital
 2024-04-01
NCT03463317 COMPLETED
Atrial Fibrillation
Charite University, Berlin, Germany
 2018-02-28 PHASE4
NCT06441916 UNKNOWN
Healthy Volunteer; Dabigatran; Bioequivalence Study
International Bio service
 2024-09-25 PHASE1
NCT06504862 COMPLETED
Healthy
Boehringer Ingelheim
 2024-08-20 PHASE1
NCT06551415 UNKNOWN
Cerebral Venous Sinus Thrombosis
Kafrelsheikh University
 2021-08-01 PHASE3
NCT06329895 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
 2024-03-25 PHASE1
NCT05747768 UNKNOWN
Chronic Kidney Disease
Peking University Third Hospital
 2022-07-15 PHASE4
NCT04684212 WITHDRAWN
Atrial Fibrillation; Left Atrial Appendage Thrombosis; CVA
Brian O'Neill MD
 2024-06-01
NCT03996772 COMPLETED
Atrial Fibrillation; Intracerebral Hemorrhage
Imperial College London
 2019-06-03 PHASE3
NCT06360055 Recruiting
Health
Peking University Third Hospital
 2024-04-01 Not Applicable
NCT03539055 COMPLETED
Atrial Fibrillation; Device Related Thrombus; Left Atrial Appendage Thrombosis; Watchman LAA Closure Device
Vanderbilt University Medical Center
 2018-09-01 PHASE4
NCT05491460 UNKNOWN
Anticoagulant Therapy
Doasense GmbH
 2022-07-01 PHASE1
NCT05959447 COMPLETED
Cough; Healthy
Bellus Health Inc. - a GSK company
 2023-07-26 PHASE1
NCT05966740 Recruiting
Venous Thromboembolism
Boehringer Ingelheim|Children''s Hospital Acquired Thrombosis consortium
 2023-10-31 --
NCT05788328 TERMINATED
Healthy
Pfizer
 2023-03-27 PHASE1
NCT05715658 UNKNOWN
Nonvalvular Atrial Fibrillation; Health, Subjective
Dongyang Liu
 2022-08-15
NCT05673889 COMPLETED
Healthy
Pfizer
 2023-01-27 PHASE1
NCT04002011 WITHDRAWN
Anticoagulant-induced Bleeding
Laval University
 2022-03-09 PHASE2
NCT05673889 Completed
Healthy
Pfizer|Arvinas Estrogen Receptor Inc.
 2023-01-27 Phase 1
NCT04688723 UNKNOWN
Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Atrial Fibrillation
Zuyderland Medisch Centrum
 2020-12-23 PHASE4
NCT03148457 COMPLETED
Ischaemic Stroke
Insel Gruppe AG, University Hospital Bern
 2017-11-06
NCT05438303 COMPLETED
Healthy Volunteers
AstraZeneca
 2022-06-13 PHASE1
NCT05471817 COMPLETED
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Hot Flashes; Healthy Volunteers
Bayer
 2022-08-05 PHASE1
NCT05480475 COMPLETED
Healthy
Idorsia Pharmaceuticals Ltd.
 2022-09-03 PHASE1
NCT05347979 COMPLETED
Cushing Syndrome; Neoplasms
Corcept Therapeutics
 2022-05-25 PHASE1
NCT04433481 UNKNOWN
Liver Cirrhosis; Portal Vein Thrombosis
Institute of Liver and Biliary Sciences, India
 2020-06-20
NCT05492318 COMPLETED
Drug-Drug Interaction; Heathy Volunteer
Italfarmaco
 2022-03-21 PHASE1
NCT03752294 WITHDRAWN
Mild Cognitive Impairment; Mild Alzheimer's Disease
University of Rhode Island
 2019-05 PHASE1
NCT05368805 COMPLETED
Metastatic Colorectal Cancer
Hutchmed
 2022-03-02 PHASE1
NCT04157881 COMPLETED
Atrial Fibrillation; Venous Thromboembolism
Population Health Research Institute
 2020-01-03 PHASE4
NCT05064800 COMPLETED
Healthy Participants
Pfizer
 2021-09-21 PHASE1
NCT04809818 COMPLETED
Acute Ischemic Stroke
Lumosa Therapeutics Co., Ltd.
 2021-03-21 PHASE1
NCT04749914 COMPLETED
Healthy
Eli Lilly and Company
 2021-02-15 PHASE1
NCT03789695 UNKNOWN
Atrial Fibrillation; T2DM (Type 2 Diabetes Mellitus); Chronic Kidney Diseases
Irina Ermolaeva
 2018-11-14 PHASE4
NCT03240120 UNKNOWN
Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism
The University of Hong Kong
 2017-09-01 PHASE3
NCT04498741 COMPLETED
RSV Infection
Enanta Pharmaceuticals, Inc
 2020-07-08 PHASE1
NCT04782076 COMPLETED
Healthy
Loxo Oncology, Inc.
 2021-03-05 PHASE1
NCT03153150 COMPLETED
Intracranial Hemorrhages; Intracranial Hemorrhage, Hypertensive; Subarachnoid Hemorrhage; Subdural Hematoma; Intraventricular Hemorrhage; Atrial Fibrillation; Atrial Flutter; Small Vessel Cerebrovascular Disease; Microhaemorrhage
University of Edinburgh
 2018-03-28 PHASE3
NCT04208061 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-12-18 PHASE1
NCT03061006 COMPLETED
Dementia; Cognition Disorders; Cerebral Ischemic Events
Intermountain Health Care, Inc.
 2017-03-30 PHASE4
NCT01994265 COMPLETED
Atrial Fibrillation
University of Sao Paulo
 2014-11-07 PHASE4
NCT04192552 UNKNOWN
Atrial Fibrillation
McMaster University
 2020-01-09
NCT03975062 UNKNOWN
Atrial Fibrillation
Ural State Medical University
 2017-12-28 PHASE4
NCT03181386 COMPLETED
Atrial Fibrillation; Periodontal Disease; Hemorrhage
University of Sao Paulo General Hospital
 2017-05-03 PHASE3
NCT02744092 COMPLETED
Cancer; Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Blood Clot
Alliance Foundation Trials, LLC.
 2016-12-13
NCT04459585 COMPLETED
Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Daiichi Sankyo Co., Ltd.
 2020-08-28 EARLY_PHASE1
NCT02982850 COMPLETED
Atrial Fibrillation; Valve Heart Disease
Asan Medical Center
 2016-12 PHASE4
NCT04257032 COMPLETED
Healthy
Boehringer Ingelheim
 2020-02-13 PHASE1
NCT02067182 COMPLETED
Atrial Fibrillation; Cardioembolic Events; Oral Anticoagulation
Georg Nickenig
 2015-08 PHASE4
NCT03807856 TERMINATED
Acute Pancreatitis
Mayo Clinic
 2019-06-24 PHASE1
NCT03343704 COMPLETED
Hemorrhage
Boehringer Ingelheim
 2018-03-26 PHASE3
NCT06876623 COMPLETED
Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
The Affiliated Hospital Of Guizhou Medical University
 2019-12-10 PHASE1
NCT02596555 TERMINATED
Pulmonary Embolism
Prof. Stavros Konstantinides, MD
 2016-01 PHASE4
NCT04092725 COMPLETED
Pharmacokinetics
Scynexis, Inc.
 2019-09-09 PHASE1
NCT03536611 UNKNOWN
Atrial Fibrillation; Coronary Artery Disease
Shenyang Northern Hospital
 2018-09-01 PHASE4
NCT04099732 COMPLETED
Healthy
Boehringer Ingelheim
 2019-10-07 PHASE1
NCT02815670 COMPLETED
Hemorrhage
Boehringer Ingelheim
 2016-09-07 PHASE3
NCT02197416 COMPLETED
Venous Thromboembolism; Secondary Prevention
Boehringer Ingelheim
 2014-09-29 PHASE3
NCT01895777 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2013-09-25 PHASE3
NCT02935855 COMPLETED
Diabetes
University of Pavia
 2015-09 PHASE4
NCT03742336 COMPLETED
Healthy
Pfizer
 2018-11-21 PHASE1
NCT03217448 UNKNOWN
Cerebral Venous Thrombosis
Capital Medical University
 2017-10-30 PHASE3
NCT02295826 COMPLETED
Transient Ischemic Attack; Minor Ischemic Stroke
University of Alberta
 2015-01 PHASE2
NCT03728101 COMPLETED
Healthy
Korea University Guro Hospital
 2018-11-16 PHASE1
NCT02666157 UNKNOWN
Atrial Fibrillation
National Cheng-Kung University Hospital
 2016-01 PHASE4
NCT03492437 COMPLETED
Healthy
Merck KGaA, Darmstadt, Germany
 2018-05-17 PHASE1
NCT02239120 COMPLETED
Stroke; Secondary Prevention
Boehringer Ingelheim
 2014-11-27 PHASE3
NCT03311841 COMPLETED
Renal Insufficiency
Merck Sharp & Dohme LLC
 2018-03-01 PHASE1
NCT03183843 UNKNOWN
Mitral Valve Stenosis and Insufficiency; Atrial Fibrillation
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
 2016-06-29 PHASE4
NCT02913326 COMPLETED
Thromboembolism
Boehringer Ingelheim
 2016-12-13 PHASE3
NCT03495739 UNKNOWN
Healthy
Huons Co., Ltd.
 2018-02-01 PHASE1
NCT02426229 COMPLETED
Scleroderma; Interstitial Lung Disease
Medical University of South Carolina
 2016-02 PHASE1
NCT02979561 UNKNOWN
Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy
Meshalkin Research Institute of Pathology of Circulation
 2016-10 PHASE4
NCT02723981 WITHDRAWN
Stable Angina; Unstable Angina; STEMI; NSTEMI; Coronary Disease
IHF GmbH - Institut für Herzinfarktforschung
 2016-04 PHASE4
NCT02256683 TERMINATED
Atrial Fibrillation or Atrial Flutter; Thrombosis of Left Atrial Appendage
Johannes Gutenberg University Mainz
 2014-07 PHASE2
NCT01661101 COMPLETED
Myocardial Injury After Noncardiac Surgery (MINS)
Population Health Research Institute
 2013-01 PHASE3
NCT02646267 UNKNOWN
Atrial Fibrillation
The First Affiliated Hospital with Nanjing Medical University
 2016-03 PHASE4
NCT02591225 UNKNOWN
Atrial Fibrillation; Left Atrial Thrombosis
University of Ulm
 2015-10 PHASE4
NCT03237416 COMPLETED
Prostatic Neoplasms
Bayer
 2017-08-02 PHASE1
NCT01675076 COMPLETED
Hematoma
Ottawa Heart Institute Research Corporation
 2013-01 PHASE3
NCT03086356 COMPLETED
Healthy Volunteers
Boehringer Ingelheim
 2017-05-10 PHASE1
NCT02544932 UNKNOWN
Atrial Fibrillation
Kyunghee University Medical Center
 2015-10 PHASE3
NCT02885961 UNKNOWN
Idiopathic Pulmonary Fibrosis; IPF; Interstitial Lung Disease
University College, London
 2016-08
NCT03143166 COMPLETED
Non-alcoholic Fatty Liver Disease
Boehringer Ingelheim
 2017-05-22 PHASE1
NCT03070171 COMPLETED
Healthy
Boehringer Ingelheim
 2017-03-21 PHASE1
NCT02164864 COMPLETED
Atrial Fibrillation; Percutaneous Coronary Intervention
Boehringer Ingelheim
 2014-07-22 PHASE3
NCT01896622 COMPLETED
HIV
National Institutes of Health Clinical Center (CC)
 2013-06-18 PHASE1
NCT02945020 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-11-10 PHASE1
NCT01468155 COMPLETED
Atrial Fibrillation
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2011-07-13 PHASE4
NCT00562289 COMPLETED
Ischemic Stroke; Patent Foramen Ovale; Atrial Septal Aneurysm; Migraine
Assistance Publique - Hôpitaux de Paris
 2007-12 PHASE3
NCT01976507 COMPLETED
Atrial Fibrillation; Atrial Flutter
Vanderbilt University Medical Center
 2013-10 PHASE4
NCT02348723 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2015-04-28 PHASE4
NCT02831660 COMPLETED
Hemorrhage
Boehringer Ingelheim
 2016-07-22 PHASE3
NCT02361619 COMPLETED
Healthy Volunteers
Turku University Hospital
 2015-02 PHASE1
NCT02313584 UNKNOWN
Atrial Fibrillation; Thromboembolism
Korea University
 2014-12 PHASE3
NCT02104947 COMPLETED
Hemorrhage
Boehringer Ingelheim
 2014-05-06 PHASE3
NCT02463591 UNKNOWN
Drug Action Reversal
University Medical Center Groningen
 2015-01 PHASE2
NCT02710630 COMPLETED
Healthy
Boehringer Ingelheim
 2016-03-22 PHASE1
NCT01083732 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2010-03 PHASE2
NCT02568397 COMPLETED
Healthy
AstraZeneca
 2015-10-31 PHASE1
NCT02223260 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2014-09 PHASE2
NCT01773174 WITHDRAWN
Venous Thromboembolism
Boehringer Ingelheim
 2013-01 PHASE2
NCT02389582 COMPLETED
Coronary Disease
University of Sao Paulo General Hospital
 2014-05 PHASE4
NCT02331602 UNKNOWN
Atrial Fibrillation
Yokohama City University Medical Center
 2013-07 PHASE4
NCT01896297 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2013-07 PHASE4
NCT02872649 TERMINATED
Thrombosis; Bleeding
Daniel Zimpfer, MD
 2013-01 PHASE2
NCT02524210 COMPLETED
Healthy
Centre Hospitalier Universitaire de Saint Etienne
 2014-05 PHASE1
NCT01593150 COMPLETED
Atrial Fibrillation
Odense University Hospital
 2011-11
NCT01361763 UNKNOWN
CADASIL
S. Andrea Hospital
 2011-06 PHASE2
NCT01431456 COMPLETED
Venous Thromboembolism
Martini Hospital Groningen
 2013-09 PHASE3
NCT01868243 TERMINATED
Primary Disease
Hospital Ana Nery
 2013-08 PHASE2; PHASE3
NCT02028780 COMPLETED
Healthy
Boehringer Ingelheim
 2014-01 PHASE1
NCT01493557 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2011-12 PHASE4
NCT01578044 COMPLETED
Atrial Fibrillation
VA Office of Research and Development
 2012-01
NCT01627665 COMPLETED
Healthy Volunteers
Assistance Publique - Hôpitaux de Paris
 2011-10 PHASE2; PHASE3
NCT02102633 COMPLETED
Healthy
Pfizer
 2014-05 PHASE1
NCT01352702 TERMINATED
Coronary Heart Disease; Atrial Fibrillation; Acute Coronary Syndrome; Atherosclerosis
Deutsches Herzzentrum Muenchen
 2011-05 PHASE4
NCT01769703 COMPLETED
Transient Ischemic Attack; Minor Ischemic Stroke
University of Alberta
 2012-02 PHASE2
NCT01955720 COMPLETED
Hemorrhage
Boehringer Ingelheim
 2013-09 PHASE1
NCT02044367 COMPLETED
Healthy
Boehringer Ingelheim
 2014-01 PHASE1
NCT02085824 UNKNOWN
Hip Osteoarthritis; Blood Loss
Centre of Postgraduate Medical Education
 2012-07
NCT01852162 COMPLETED
Coronary Artery Disease
University of Florida
 2012-02
NCT01711853 COMPLETED
Renal Insufficiency, Chronic
Boehringer Ingelheim
 2012-10 PHASE1
NCT01546883 TERMINATED
Atrial Fibrillation
University of Utah
 2012-02 PHASE4
NCT01688830 COMPLETED
Healthy
Boehringer Ingelheim
 2012-09 PHASE1
NCT01810237 WITHDRAWN
Venous Thromboses
Nova Scotia Health Authority
 2013-03
NCT01452347 TERMINATED
Heart Valve Diseases
Boehringer Ingelheim
 2011-10 PHASE2
NCT01505881 TERMINATED
Thromboembolism; Heart Valve Prosthesis
Boehringer Ingelheim
 2011-12 PHASE2
NCT01734772 COMPLETED
Healthy
Boehringer Ingelheim
 2012-11 PHASE1
NCT01812200 COMPLETED
Atrial Fibrillation; Acute Coronary Syndrome
Medical University of Vienna
 2012-10 PHASE4
NCT01184989 COMPLETED
Arthroplasty, Replacement; Prevention of Venous Thromboembolism; Moderate Renal Impairment (CrCl 30-50 mL/Min)
Boehringer Ingelheim
 2010-08 PHASE4
NCT01478282 UNKNOWN
Thrombosis; Anticoagulant-induced Bleeding; Anticoagulant Overdosage; Hemorrhage
Gines Escolar
 2012-01 PHASE4
NCT00808067 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2008-11 PHASE3
NCT01590823 COMPLETED
Blood Coagulation Disorders
Nova Scotia Health Authority
 2012-07 PHASE1
NCT01595854 COMPLETED
Healthy
Boehringer Ingelheim
 2012-05 PHASE1
NCT01339819 COMPLETED
Atrial Fibrillation
Deutsches Herzzentrum Muenchen
 2011-04 PHASE4
NCT00844415 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2009-06-01 PHASE2
NCT01385683 COMPLETED
Healthy
Centre Hospitalier Universitaire de Saint Etienne
 2011-06 PHASE1
NCT01379300 COMPLETED
Thrombosis
Merck Sharp & Dohme LLC
 2011-05 PHASE1
NCT00680186 COMPLETED
Thromboembolism
Boehringer Ingelheim
 2008-04 PHASE3
NCT01306162 COMPLETED
Healthy
Boehringer Ingelheim
 2011-02 PHASE1
NCT01241539 COMPLETED
Cardiovascular Diseases; Kidney Failure, Chronic
Boehringer Ingelheim
 2010-11 PHASE1
NCT01290757 COMPLETED
Healthy
Boehringer Ingelheim
 2011-01 PHASE1
NCT01210755 COMPLETED
Venous Thromboembolism
University Hospital, Grenoble
 2010-11 PHASE4
NCT00558259 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2007-11 PHASE3
NCT00329238 COMPLETED
Thromboembolism
Boehringer Ingelheim
 2006-05 PHASE3
NCT00818753 COMPLETED
Heart Catheterization
Boehringer Ingelheim
 2009-01 PHASE2
NCT02171572 COMPLETED
Healthy
Boehringer Ingelheim
 2009-10 PHASE1
NCT00621855 COMPLETED
Coronary Disease
Boehringer Ingelheim
 2008-03 PHASE2
NCT00657150 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2008-03 PHASE3
NCT02173717 COMPLETED
Healthy
Boehringer Ingelheim
 2009-06 PHASE1
NCT02171598 COMPLETED
Healthy
Boehringer Ingelheim
 2009-02 PHASE1
NCT02170675 COMPLETED
Healthy
Boehringer Ingelheim
 2009-06 PHASE1
NCT02171611 COMPLETED
Healthy
Boehringer Ingelheim
 2009-03 PHASE1
NCT00291330 COMPLETED
Thromboembolism
Boehringer Ingelheim
 2006-02 PHASE3
NCT02171624 COMPLETED
Healthy
Boehringer Ingelheim
 2009-03 PHASE1
NCT00262600 COMPLETED
Atrial Fibrillation; Stroke
Boehringer Ingelheim
 2005-12 PHASE3
NCT00157248 TERMINATED
Atrial Fibrillation; Stroke
Boehringer Ingelheim
 2003-12 PHASE2
NCT02171559 COMPLETED
Healthy
Boehringer Ingelheim
 2008-08 PHASE1
NCT02171533 COMPLETED
Healthy
Boehringer Ingelheim
 2008-06 PHASE1
NCT02171520 COMPLETED
Healthy
Boehringer Ingelheim
 2008-05 PHASE1
NCT02171481 COMPLETED
Healthy
Boehringer Ingelheim
 2008-05 PHASE1
NCT02171585 COMPLETED
Healthy
Boehringer Ingelheim
 2008-06 PHASE1
NCT02171546 TERMINATED
Healthy
Boehringer Ingelheim
 2007-11 PHASE1
NCT00246025 COMPLETED
Arthroplasty, Replacement, Knee; Venous Thrombosis
Boehringer Ingelheim
 2005-10 PHASE2
NCT01136408 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2005-11 PHASE2
NCT02171052 COMPLETED
Healthy
Boehringer Ingelheim
 2006-06 PHASE1
NCT02171039 COMPLETED
Healthy
Boehringer Ingelheim
 2006-06 PHASE1
NCT02171468 COMPLETED
Healthy
Boehringer Ingelheim
 2006-05 PHASE1
NCT02171013 COMPLETED
Healthy
Boehringer Ingelheim
 2006-04 PHASE1
NCT00168818 COMPLETED
Thromboembolism; Arthroplasty, Replacement, Hip
Boehringer Ingelheim
 2004-11 PHASE3
NCT02171507 COMPLETED
Healthy
Boehringer Ingelheim
 2006-05 PHASE1
NCT02171026 COMPLETED
Healthy
Boehringer Ingelheim
 2006-04 PHASE1
NCT00152971 COMPLETED
Arthroplasty, Replacement, Knee; Thromboembolism
Boehringer Ingelheim
 2004-11 PHASE3
NCT02170987 COMPLETED
Healthy
Boehringer Ingelheim
 2006-03 PHASE1
NCT00168805 COMPLETED
Arthroplasty, Replacement, Knee; Thromboembolism
Boehringer Ingelheim
 2004-11 PHASE3
NCT02182024 COMPLETED
Renal Insufficiency
Boehringer Ingelheim
 2005-04 PHASE1
NCT02171455 COMPLETED
Healthy
Boehringer Ingelheim
 2006-01 PHASE1
NCT02170571 COMPLETED
Hepatic Insufficiency
Boehringer Ingelheim
 2005-07 PHASE1
NCT02170909 COMPLETED
Healthy
Boehringer Ingelheim
 2004-12 PHASE1
NCT02171000 COMPLETED
Healthy
Boehringer Ingelheim
 2005-04 PHASE1
NCT01227629 COMPLETED
Atrial Fibrillation
Boehringer Ingelheim
 2003-09 PHASE2
NCT02170974 COMPLETED
Healthy
Boehringer Ingelheim
 2004-07 PHASE1
NCT02170844 COMPLETED
Healthy
Boehringer Ingelheim
 2004-06 PHASE1
NCT02170597 COMPLETED
Healthy
Boehringer Ingelheim
 2003-08 PHASE1
NCT01225822 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2002-11 PHASE2
NCT02173730 COMPLETED
Healthy
Boehringer Ingelheim
 2002-11 PHASE1
NCT02170935 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2002-04 PHASE2
NCT02170610 COMPLETED
Healthy
Boehringer Ingelheim
 2002-03 PHASE1
NCT02171442 COMPLETED
Healthy
Boehringer Ingelheim
 2002-04 PHASE1
NCT02170623 COMPLETED
Healthy
Boehringer Ingelheim
 2002-02 PHASE1
NCT02170636 COMPLETED
Healthy
Boehringer Ingelheim
 2002-01 PHASE1
NCT02170896 COMPLETED
Healthy
Boehringer Ingelheim
 2001-10 PHASE1
NCT02170805 COMPLETED
Healthy
Boehringer Ingelheim
 2001-04 PHASE1
NCT02170701 COMPLETED
Venous Thromboembolism
Boehringer Ingelheim
 2000-10 PHASE2
NCT02170792 COMPLETED
Healthy
Boehringer Ingelheim
 2001-02 PHASE1
NCT02170584 COMPLETED
Healthy
Boehringer Ingelheim
 2001-01 PHASE1
NCT02170766 COMPLETED
Healthy
Boehringer Ingelheim
 2000-10 PHASE1
NCT02170740 COMPLETED
Healthy
Boehringer Ingelheim
 1999-11 PHASE1
NCT02170922 COMPLETED
Healthy
Boehringer Ingelheim
 1999-07 PHASE1
NCT02170831 COMPLETED
Healthy
Boehringer Ingelheim
 1999-05 PHASE1
NCT02170116 COMPLETED
Healthy
Boehringer Ingelheim
 1998-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the Dabigatran (BIBR-1048) etexilate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dabigatran etexilate is an orally bioavailable prodrug that is hydrolyzed to dabigatran, a direct small-molecule inhibitor that specifically and reversibly binds the active site of free and clot-bound thrombin to prevent fibrinogen cleavage and block thrombin-mediated platelet activation. This potent suppression of the coagulation cascade halts intravascular clot formation, establishing its therapeutic efficacy in reducing the risk of stroke in atrial fibrillation and treating venous thromboembolism.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.