Drugs / Dabigatran etexilate
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Dabigatran etexilate

Developed for
venous thromboembolism · atrial fibrillation · chronic kidney disease · thrombotic disease · osteoarthritis, knee · atrial flutter · brain ischemia · cerebral sinovenous thrombosis
+10 more · coronary artery disorder · dementia · heart valve disorder · interstitial lung disease · ischemic stroke · pulmonary embolism · scleroderma · stroke disorder · type 2 diabetes mellitus · acute pancreatitis
Investigated by
Boehringer Ingelheim · Bayer · Pfizer · Peking University Third Hospital · AstraZeneca · Eli Lilly and Company
+34 more · Janssen Research & Development, LLC · Merck Sharp & Dohme LLC · Vanderbilt University Medical Center · Arvinas Estrogen Receptor, Inc. · Atrial Fibrillation Network · Bellus Health Inc. - a GSK company · Capital Health, Canada · Capital Medical University · Corcept Therapeutics · Daiichi Sankyo · Dalhousie University · Dongyang Liu · Hutchmed · Idorsia Pharmaceuticals Ltd. · Imperial College London · Intermountain Health Care, Inc. · Irina Ermolaeva · Italfarmaco · Johannes Gutenberg University Mainz · Korea University Guro Hospital · Medical University of South Carolina · Merck KGaA, Darmstadt, Germany · Meshalkin Research Institute of Pathology of Circulation · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Nova Scotia Health Authority · Odense University Hospital · Orion Corporation, Orion Pharma · The University of Hong Kong · University of Montreal · University of Ulm · University of Utah · Uppsala University · Ural State Medical University · ViiV Healthcare

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) PRADAXA 2014-04-04 – 2021-06-21 fda.gov
Approved US (FDA) PRADAXA 2010-10-19 fda.gov
Approved EU (EMA) Pradaxa 2008-03-17 europa.eu

Trials 113 · started per year

today
EU approved 2008
US approved 2010
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199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04459585 Aug → Oct 2020 Daiichi Sankyo Completed No outcome recorded
Phase 168 trials
Phase 1 NCT07515339 Apr → Jun 2026 chronic kidney disease Bayer Withdrawn No outcome recorded
Phase 1 NCT07190430 Oct → Dec 2025 overdue atopic eczema Pfizer Active not recruiting No outcome recorded
Phase 1 NCT06791187 Jan → Feb 2025 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06693518 Nov 2024 → Jan 2025 COVID-19 Pfizer Completed No outcome recorded
Phase 1 NCT06504862 Aug → Oct 2024 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06533280 Aug 2024 HIV infectious disease ViiV Healthcare Withdrawn No outcome recorded
Phase 1 NCT06329895 Mar → Jun 2024 non-small cell lung carcinoma Bayer Completed No outcome recorded
Phase 1 NCT05959447 Jul → Oct 2023 Bellus Health Inc. - a GSK company Completed No outcome recorded
Phase 1 NCT05788328 Mar → Sep 2023 Pfizer Terminated No outcome recorded
Phase 1 NCT05673889 Jan → Mar 2023 Pfizer Completed No outcome recorded
Phase 213 trials
Phase 2 NCT02256683 Jul 2014 → May 2018 atrial fibrillation Johannes Gutenberg University Mainz Terminated No outcome recorded
Phase 2 NCT01773174 Jan 2013 → Dec 2015 venous thromboembolism Boehringer Ingelheim Withdrawn No outcome recorded
Phase 2 NCT01505881 Dec 2011 → Jun 2013 cardiac valvular defect, thrombotic disease Boehringer Ingelheim Terminated No outcome recorded
Phase 2 NCT01452347 Oct 2011 → Jun 2013 heart valve disorder Boehringer Ingelheim Terminated No outcome recorded
Phase 2 NCT01083732 Mar 2010 → Feb 2016 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT00844415 Jun 2009 → Feb 2012 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT00621855 Mar 2008 → Oct 2009 coronary artery disorder Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT01136408 Nov 2005 → Sep 2006 atrial fibrillation Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT00246025 Oct 2005 → Jun 2007 osteoarthritis, knee, venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 2 NCT00157248 Dec 2003 → Jan 2009 atrial fibrillation, stroke disorder Boehringer Ingelheim Terminated No outcome recorded
Phase 314 trials
Phase 3 NCT03217448 Oct 2017 → Jan 2019 cerebral sinovenous thrombosis Capital Medical University Unknown No outcome recorded
Phase 3 NCT03240120 Sep 2017 → May 2021 pulmonary embolism, venous thromboembolism The University of Hong Kong Unknown No outcome recorded
Phase 3 NCT02913326 Dec 2016 → Jun 2018 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02239120 Nov 2014 → Aug 2018 ischemic stroke Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02197416 Sep 2014 → Oct 2019 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT02164864 Jul 2014 → Jun 2017 atrial fibrillation Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT01895777 Sep 2013 → Oct 2019 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00680186 Apr 2008 → May 2011 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00657150 Mar 2008 → Sep 2009 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00558259 Nov 2007 → Feb 2011 venous thromboembolism Boehringer Ingelheim Completed No outcome recorded
Phase 414 trials
Phase 4 NCT05735639 Jan 2024 → Jun 2027 expected varicose disease, venous thromboembolism Imperial College London Recruiting No outcome recorded
Phase 4 NCT06273215 Mar 2023 → Dec 2025 diabetes mellitus Peking University Third Hospital Unknown No outcome recorded
Phase 4 NCT05747768 Jul 2022 → Jun 2024 chronic kidney disease Peking University Third Hospital Unknown No outcome recorded
Phase 4 NCT03789695 Nov 2018 → Jul 2021 atrial fibrillation, chronic kidney disease, type 2 diabetes mellitus Irina Ermolaeva Unknown No outcome recorded
Phase 4 NCT03539055 Sep 2018 → Dec 2023 atrial fibrillation, thrombotic disease Vanderbilt University Medical Center Completed No outcome recorded
Phase 4 NCT03975062 Dec 2017 → Dec 2020 atrial fibrillation Ural State Medical University Unknown No outcome recorded
Phase 4 NCT03061006 Mar 2017 → Mar 2021 brain ischemia, dementia Intermountain Health Care, Inc. Completed No outcome recorded
Phase 4 NCT02979561 Oct 2016 → Jun 2018 Meshalkin Research Institute of Pathology of Circulation Unknown No outcome recorded
Phase 4 NCT02591225 Oct 2015 → Dec 2017 atrial fibrillation University of Ulm Unknown No outcome recorded
Phase 4 NCT02348723 Apr 2015 → Nov 2016 atrial fibrillation Boehringer Ingelheim Completed No outcome recorded
Phase not applicable3 trials
NCT06360055 Apr → Nov 2024 Peking University Third Hospital Unknown No outcome recorded
NCT05715658 Aug 2022 → Jun 2023 atrial fibrillation Dongyang Liu Unknown No outcome recorded
NCT01593150 Nov 2011 → Feb 2015 atrial fibrillation Odense University Hospital Completed No outcome recorded
Also used as a comparator or background therapy in 18 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT07629999 Background Jun 2026 → Jun 2027 expected Bristol-Myers Squibb Not yet recruiting No outcome recorded
Phase 1 NCT03807856 Comparator Jun 2019 → Jul 2020 acute pancreatitis Mayo Clinic Terminated No outcome recorded
Phase 1 NCT03495739 Comparator Feb → Jun 2018 Huons Co., Ltd. Unknown No outcome recorded
Phase 1 NCT02710630 Comparator Mar → May 2016 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02170974 Comparator Jul → Aug 2004 Boehringer Ingelheim Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01627665 Comparator Oct 2011 → Jun 2014 Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06551402 Comparator Aug 2024 → Oct 2026 expected cerebral sinovenous thrombosis Kafrelsheikh University Recruiting No outcome recorded
Phase 3 NCT06551415 Comparator Aug 2021 → Sep 2024 overdue cerebral sinovenous thrombosis Kafrelsheikh University Recruiting No outcome recorded
Phase 3 NCT01924065 Comparator Aug 2013 → Aug 2017 atrial fibrillation, stroke disorder Suleyman Demirel University Completed No outcome recorded
Phase 48 trials
Phase 4 NCT03129555 Comparator Apr 2023 → Mar 2027 expected pulmonary embolism, venous thromboembolism Herlev and Gentofte Hospital Active not recruiting No outcome recorded
Phase 4 NCT03129490 Comparator Apr 2023 → Oct 2027 expected atrial fibrillation, atrial flutter Herlev and Gentofte Hospital Active not recruiting No outcome recorded
Phase 4 NCT04695106 Background Oct 2021 → Jul 2026 overdue acute coronary syndrome, atrial fibrillation Medical University of Gdansk Recruiting No outcome recorded
Phase 4 NCT03183843 Comparator Jun 2016 → Jun 2018 atrial fibrillation, heart valve disorder Research Institute for Complex Problems of Cardiovascular Diseases, Russia Unknown No outcome recorded
Phase 4 NCT02646267 Comparator Mar 2016 → Jan 2018 atrial fibrillation The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 137 sources stand behind the page.

FieldValueCited text
Known as Dabigatran etexilate “The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation...” NCT02710630
108

Dabigatran etexilate (DE) is an anticoagulant with proven efficacy and tolerability for stroke prevention in patients with non-valvular atrial fibrillation.” PMID 31667735 Jun 2020

“Oral administration of probe cocktail (Midazolam, Digoxin, Total Dabigatran etexilate, Rosuvastatin) in moderate fat/moderate calorie conditions.” NCT06533280

“375/10 μg dabigatran etexilate and pitavastatin (1 mL of 375/10 μg/mL oral solution), administered orally as part of a microdose cocktail” NCT03311841

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement” NCT00152971

“OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA” NCT00559988

“Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban” NCT01627665

“warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage” NCT01924065

Dabigatran Etexilate 150 mg” NCT06693518

“Drug: Dabigatran EtexilateNCT04695106

NCT02256683

NCT00558259

NCT03129555

NCT03217448

NCT03975062

NCT01734772

NCT01306162

NCT03129490

NCT02945020

NCT07190430

NCT02044367

NCT06551415

NCT06551402

NCT05673889

NCT02171611

NCT00621855

NCT01452347

NCT00291330

NCT02182024

NCT02164864

NCT03495739

NCT05492318

NCT01773174

NCT01976507

NCT01136408

NCT02170675

NCT02197416

NCT02913326

NCT01379300

NCT03492437

NCT02348723

NCT00168805

NCT06791187

NCT00168818

NCT05747768

NCT05347979

NCT02171585

NCT02173717

NCT04749914

NCT03183843

NCT01241539

NCT03237416

NCT02426229

NCT05788328

NCT02170571

NCT02171026

NCT07515339

NCT03728101

NCT06360055

NCT07629999

NCT05715658

NCT02171572

NCT02646267

NCT02979561

NCT03143166

NCT02710630

NCT05735639

NCT02171559

NCT05959447

NCT00157248

NCT01896297

NCT02568397

NCT06273215

NCT00246025

NCT04208061

NCT03061006

NCT01590823

NCT06329895

NCT01895777

NCT03789695

NCT02591225

NCT00680186

NCT05471817

NCT01505881

NCT05480475

NCT03086356

NCT06504862

NCT04459585

NCT02239120

NCT01595854

NCT05368805

NCT03240120

NCT03539055

NCT02171455

NCT02171507

NCT01083732

NCT02171546

NCT02666157

NCT04257032

NCT01493557

NCT01184989

NCT00657150

NCT02170987

NCT02171052

NCT05438303

NCT00844415

NCT01711853

NCT02171624

NCT01546883

Known as BIBR 1048 “A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin” NCT01136408
7

NCT02170766

NCT02170701

NCT02170597

NCT02170974

NCT01225822

NCT02171442

NCT02170935

Known as BIBR 1048 MS ClinicalTrials.gov intervention name — accepted as the source's own label NCT02170922
14

NCT02170909

NCT02170844

NCT02170831

NCT02170805

NCT02170792

NCT02170636

NCT02170740

NCT02170623

NCT02171000

NCT02170610

NCT02170584

NCT02173730

NCT02170116

NCT02170896

Known as dabigatran “This trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients...” PMID 21225098 Jan 2011
7

“BACKGROUND: Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation.” PMID 23991661 Aug 2013

Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism.” PMID 23425163 Feb 2013

Dabigatran etexilate is a direct oral anticoagulant with potential to overcome the limitations of standard of care in children with venous thromboembolism.” PMID 33290737 Dec 2020

“introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time to cardioversion to a 3 week period.” NCT01593150

“Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio)” NCT02239120

Dabigatran is a drug used in the treatment of blood clots in a vein” NCT06329895

“100 CVT patients will receive dabigatran 150mg Bid for 6 months.” NCT06551415

Known as Dabigatran Etexilate 110 mg (Pradax) Dabigatran Etexilate 110 mg (Pradax)NCT01590823
Known as Dabigatran Etexilate Mesylate ClinicalTrials.gov intervention name — accepted as the source's own label NCT03807856
Known as Pradaxa “To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with...” NCT01184989
4

“Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis” NCT01241539

Pradaxa (dabigatran etexilate)” NCT01493557

Pradaxa, dabigatran etexilate” NCT01896297

NCT01593150

Action Inhibit “Our aim was to assess the oral, direct thrombin inhibitor dabigatran etexilate for such prophylaxis.” PMID 17869635 Sep 2007
Route Oral “Dabigatran Etexilate Administered Orally (Capsules)” NCT00152971