Drugs / Dabigatran etexilate
Dabigatran etexilate
also known as
BIBR 1048 MS · BIBR 1048 · dabigatran · Pradaxa · Dabigatran Etexilate 110 mg (Pradax) · Dabigatran Etexilate Mesylate
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed puerperal pulmonary embolism 2 milestones | |||||
| Filed | US (FDA) | Pradaxa | puerperal pulmonary embolism | 2013-08-28 | “The company recently announced it submitted applications to U.S. and EU regulatory authorities to review dabigatran for its use in patients with DVT and PE.” prnewswire.com ↗ |
| Filed | EU (EMA) | — | puerperal pulmonary embolism | — | “The company recently announced it submitted applications to U.S. and EU regulatory authorities to review dabigatran for its use in patients with DVT and PE.” prnewswire.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (3) | US (FDA) | PRADAXA | — | 2014-04-04 – 2021-06-21 | fda.gov ↗ |
| Filed | US (FDA) | Pradaxa | deep venous thrombosis, pulmonary embolism | 2015-04-06 | “filed a supplemental New Drug Application (sNDA) for Pradaxa ® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE)” prnewswire.com ↗ |
| Approved | US (FDA) | PRADAXA | — | 2010-10-19 | fda.gov ↗ |
| Approved | EU (EMA) | Pradaxa | — | 2008-03-17 | europa.eu ↗ |
Trials 114 · started per year
today
EU approved 2008
US approved 2010
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04459585 | Aug → Oct 2020 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 169 trials · 2 missed | ||||||
| Phase 1 | NCT07820891 | Sep → Nov 2026 expected | — | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT07515339 | Apr → Jun 2026 | chronic kidney disease | Bayer | Withdrawn | No outcome recorded |
| Phase 1 | NCT07190430 | Oct → Dec 2025 | atopic eczema | Pfizer | Completed | 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 Stop: Business |
| 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 1 | NCT05480475 | Sep 2022 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05471817 | Aug → Sep 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT05438303 | Jun → Dec 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05347979 | May → Jul 2022 | Cushing syndrome, neoplasm | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05492318 | Mar → May 2022 | — | Italfarmaco | Completed | No outcome recorded |
| Phase 1 | NCT05368805 | Mar → Apr 2022 | colorectal cancer | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT04749914 | Feb → Jul 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04257032 | Feb → Sep 2020 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT04208061 | Dec 2019 → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03728101 | Nov → Dec 2018 | — | Korea University Guro Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03492437 | May → Aug 2018 | — | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03311841 | Mar → Aug 2018 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT03237416 | Aug → Oct 2017 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03143166 | May → Jul 2017 | NAFLD1 | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03086356 | May → Sep 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02945020 | Nov 2016 → Jan 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02426229 | Feb 2016 → Jun 2018 | interstitial lung disease, scleroderma | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 1 | NCT02568397 | Oct 2015 → Jan 2016 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02044367 | Jan → Apr 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01734772 | Nov 2012 → Jun 2013 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01711853 | Oct 2012 → Dec 2013 | chronic kidney disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01590823 | Jul → Sep 2012 | blood coagulation disease | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 1 | NCT01595854 | May → Jun 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01379300 | May → Dec 2011 | thrombotic disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01306162 | Feb → May 2011 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01241539 | Nov 2010 → May 2011 | cardiovascular disorder, chronic renal failure syndrome | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171572 | Oct → Nov 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02173717 | Jun → Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170675 | Jun → Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171611 | Mar → May 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171624 | Mar → Apr 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171559 | Aug → Sep 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171585 | Jun → Aug 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171546 | Nov 2007 → Jan 2008 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02171052 | Jun → Aug 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171507 | May → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171026 | Apr → Jun 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170987 | Mar → May 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171455 | Jan 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170571 | Jul → Dec 2005 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171000 | Apr → May 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182024 | Apr 2005 → Mar 2006 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170909 | Dec 2004 → Jun 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170844 | Jun → Aug 2004 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170597 | Aug → Sep 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02173730 | Nov 2002 → Feb 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170610 | Mar → May 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170623 | Feb → Apr 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170636 | Jan → Mar 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170896 | Oct → Dec 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170805 | Apr → Jun 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170792 | Feb → Mar 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170584 | Jan → Mar 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170766 | Oct → Dec 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170740 | Nov 1999 → Jan 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170922 | Jul → Aug 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170831 | May → Jul 1999 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02170116 | Nov → Dec 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT02256683 | Jul 2014 → May 2018 | atrial fibrillation | Johannes Gutenberg University Mainz | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Met primary |
| Phase 2 | NCT00157248 | Dec 2003 → Jan 2009 | atrial fibrillation, stroke disorder | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT01225822 | Nov 2002 → Aug 2003 | venous thromboembolism | Boehringer Ingelheim | Completed | Mixed |
| Phase 2 | NCT02170935 | Apr → Jun 2002 | venous thromboembolism | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02170701 | Oct 2000 → Jun 2001 | venous thromboembolism | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 314 trials · 7 met primary · 2 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01895777 | Sep 2013 → Oct 2019 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00680186 | Apr 2008 → May 2011 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00657150 | Mar 2008 → Sep 2009 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00558259 | Nov 2007 → Feb 2011 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00291330 | Feb 2006 → May 2009 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00168818 | Nov 2004 → Jul 2006 | venous thromboembolism | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00168805 | Nov 2004 → May 2006 | osteoarthritis, knee, thrombotic disease | Boehringer Ingelheim | Completed | Missed primary |
| Phase 3 | NCT00152971 | Nov 2004 → Jun 2006 | venous thromboembolism | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 414 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 4 | NCT01976507 | Oct 2013 → Dec 2016 | atrial fibrillation, atrial flutter | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01896297 | Jul 2013 → Oct 2015 | atrial fibrillation | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT01546883 | Feb 2012 → Dec 2013 | atrial fibrillation | University of Utah | Terminated | No outcome recorded |
| Phase 4 | NCT01184989 | Aug 2010 → Apr 2013 | arthropathy, erosive, venous thromboembolism | 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 |
| Comparator or background therapy18 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 Stop: Enrollment |
| 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 1 | NCT02171442 Comparator | Apr → May 2002 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/3 | NCT01627665 Comparator | Oct 2011 → Jun 2014 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| 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 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 |
| Phase 4 | NCT02666157 Comparator | Jan 2016 → Dec 2018 | atrial fibrillation | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01493557 Comparator | Dec 2011 → Jul 2014 | atrial fibrillation | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT00559988 Background | Feb 2008 → Jun 2013 | arterial occlusion, atrial fibrillation, atrial flutter, stroke disorder | Biotronik, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 60
| Date | Issuer | Release |
|---|---|---|
| 2024-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 13th August, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dabigatran Etexilate Capsules, 110 mg. |
| 2024-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 18th June, 2024, Vadodara, India alembicpharmaceuticals.com ↗
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). |
| 2024-03-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio bms.com ↗ |
| 2022-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory 7th April, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. |
| 2021-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Tentative Approval Dabigatran Etexilate Capsules alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. |
| 2020-12-21 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA tentative approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Ltd (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa®1 Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2019-09-01 | Bristol-Myers Squibb | Results Findings Released from NAXOS, a French Real-World Data Analysis and the Largest Real-World Data Analysis on Oral Anticoagulant Effectiveness and Safety in Europe Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Results show Eliquis was associated with a lower rate of major bleeding and comparable rates of stroke and systemic thromboembolic events versus dabigatran or rivaroxaban |
| 2019-07-08 | Boehringer Ingelheim | Results New data show efficacy and safety of Pradaxa® in the management of VTE in children prnewswire.com ↗
The Phase IIb/III DIVERSITY study showed Pradaxa to be as effective and to have a comparable safety profile to the current standard of care (SOC) for the treatment of acute venous thromboembolism (VTE) in children. |
| 2018-11-11 | Bristol-Myers Squibb | Results Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation bms.com ↗
Eliquis ® (apixaban) was associated with lower rates of stroke or systemic embolism and major bleeding in elderly patient populations when compared to rivaroxaban and dabigatran |
| 2018-03-11 | Pfizer | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants pfizer.com ↗
This is the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis® (apixaban), rivaroxaban and dabigatran, to date. |
| 2018-03-11 | Bristol-Myers Squibb | Results Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants bms.com ↗
Eliquis ® (apixaban) use was associated with lower rates of stroke or systemic embolism and major bleeding than matched patients receiving rivaroxaban or dabigatran |
| 2018-01-25 | Boehringer Ingelheim | Results New Real-World Analysis Finds Lower Risk of Major Bleeding and Similar Risk of Stroke with Standard Dose of Pradaxa® Compared to Rivaroxaban in NVAF Patients Newly Initiating Treatment prnewswire.com ↗ |
| 2017-08-27 | Boehringer Ingelheim | Results RE-DUAL PCI™ Results Offer Favorable New Safety Data on Pradaxa® prnewswire.com ↗
The findings were presented today at a late-breaking spotlight session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain and simultaneously published in the New England Journal of Medicine . |
| 2017-07-11 | Boehringer Ingelheim | Results Final Phase III Study Results Reinforces Safety and Efficacy of Praxbind® as Reversal Agent for Pradaxa® Patients in Emergency Situations prnewswire.com ↗
The study shows that idarucizumab, marketed in the U.S. as Praxbind®, was able to immediately reverse the anticoagulant effect of Pradaxa® (dabigatran etexilate mesylate) in patients in emergency situations. |
| 2017-03-19 | Boehringer Ingelheim | Results Uninterrupted Pradaxa® (dabigatran etexilate mesylate) Showed Less Major Bleeding than Warfarin in Atrial Fibrillation Patients Undergoing Catheter Ablation prnewswire.com ↗
In the RE-CIRCUIT trial, uninterrupted PRADAXA significantly reduced the risk of major bleeding complications compared with uninterrupted warfarin. |
| 2017-02-24 | Boehringer Ingelheim | Results Real-World Data from Boehringer Ingelheim Show Lower Risk of Stroke and Major Bleeding for Pradaxa® (dabigatran etexilate mesylate) Compared to Warfarin prnewswire.com ↗
Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). |
| 2016-12-04 | Boehringer Ingelheim | Results New Data Show High Adherence Rates with Pradaxa® (dabigatran etexilate mesylate) in NVAF Patients prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a new analysis of the GLORIA™-AF Registry Program, which showed that newly diagnosed non-valvular atrial fibrillation (NVAF) patients treated with Pradaxa ® (dabigatran etexilate mesylate) had a 76.6 percent probability of remaining on treatment at one year and a 69.2 percent probability at two years. |
| 2016-11-15 | Boehringer Ingelheim | Results Updated Phase III Results Reinforce Safety and Efficacy of Praxbind® (idarucizumab) in Urgent Situations prnewswire.com ↗
The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100). |
| 2016-11-14 | Boehringer Ingelheim | Results First Data from Boehringer Ingelheim, Anthem and HealthCore Multi-Year Study Show Gaps in Non-valvular Atrial Fibrillation Care prnewswire.com ↗
Although treatment guidelines recommend OAC treatment for all NVAF patients at high stroke risk (i.e., CHADS 2 score ≥2), researchers found less than half (41.1 percent) of the study patients were treated with an OAC (warfarin, dabigatran, rivaroxaban or apixaban). |
| 2016-10-21 | Boehringer Ingelheim | Results New Real-World Data Show Pradaxa® (dabigatran etexilate mesylate) Treatment Resulted in Less Use of All-Cause Healthcare Resources than Warfarin Treatment prnewswire.com ↗
The analysis shows that patients treated with PRADAXA experienced fewer all-cause annual hospitalizations, emergency room (ER) visits and physician office visits, than those treated with warfarin. |
| 2016-08-29 | Boehringer Ingelheim | Results ESC Congress 2016 Late Breaking Science Registry: Latest Data on Pradaxa® (dabigatran etexilate mesylate) Safety and Effectiveness Profile Show Low Rates of Bleeding and Stroke in NVAF Patients in Routine Clinical Care prnewswire.com ↗
First outcome results from the GLORIA™-AF Registry show that treatment with Pradaxa® (dabigatran etexilate mesylate) was associated with low incidences of stroke, major bleeding and life-threatening bleeding. |
| 2016-04-02 | Boehringer Ingelheim | Results Interim Phase III Data Show Praxbind® (idarucizumab) Reverses Dabigatran (Pradaxa®) in Emergency Situations prnewswire.com ↗ |
| 2015-11-23 | Boehringer Ingelheim | Regulatory FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Prophylaxis of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) after Hip Replacement Surgery prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. |
| 2015-11-09 | Boehringer Ingelheim | Results Real-World Analysis of More Than 44,000 Patients Reinforces Safety and Effectiveness of Pradaxa® (dabigatran etexilate mesylate) in Routine Clinical Care prnewswire.com ↗
Brigham and Women's Hospital in Boston and Boehringer Ingelheim today announced the results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa® (dabigatran etexilate mesylate) relative to warfarin in routine clinical practice. |
| 2015-11-09 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Praxbind® (idarucizumab) Analyses on Reintroduction of Antithrombotic Therapy after Reversal of Dabigatran prnewswire.com ↗
Reinitiation of PRADAXA after treatment with idarucizumab ranged from 1.3 days to 90.6 days in patients with uncontrolled or life-threatening bleeding, and 1 day to 63.31 days in patients requiring emergency surgery or an urgent procedure. |
| 2015-06-22 | Boehringer Ingelheim | Results Idarucizumab* Reverses the Anticoagulant Effect of Dabigatran Within Minutes in Patient Study prnewswire.com ↗
Results from an interim analysis of the Phase III RE-VERSE AD™ patient study demonstrate that 5 g of idarucizumab* immediately reversed the anticoagulant effect of dabigatran (Pradaxa ® dabigatran etexilate mesylate) in patients requiring urgent anticoagulant reversal. |
| 2015-06-16 | Boehringer Ingelheim | Results Phase I Data Published in The Lancet Show Boehringer Ingelheim's Idarucizumab* Reverses Anticoagulant Effects of Dabigatran prnewswire.com ↗
Results showed that idarucizumab immediately and completely reversed dabigatran-induced anticoagulation and no procoagulant effects were found when measured by a specific assay. |
| 2015-04-06 | Boehringer Ingelheim | Regulatory FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa® (dabigatran etexilate mesylate) for the Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism After Hip Replacement Surgery prnewswire.com ↗
The acceptance of this sNDA is another step toward expanding the therapeutic uses for PRADAXA to improve patient outcomes in this population. |
| 2015-03-16 | Boehringer Ingelheim | Results New Data from Boehringer Ingelheim's GLORIA™-AF Registry Show Non-Valvular Atrial Fibrillation (NVAF) Patients at High Risk of Stroke May Be Undertreated prnewswire.com ↗
Newer drugs known as novel oral anticoagulants (NOACs) accounted for 52.1 percent of anticoagulants prescribed (25.0 percent dabigatran, 20.5 percent rivaroxaban, and 6.6 percent apixaban). |
| 2014-12-08 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Reverses Anticoagulant Effects of Dabigatran (PRADAXA®) in Middle-Aged, Elderly and Renally Impaired Volunteers prnewswire.com ↗
Further, anticoagulation was restored when volunteers were re-dosed with dabigatran 24 hours after idarucizumab was administered. |
| 2014-11-18 | Boehringer Ingelheim | Results New Data Show Idarucizumab* Restores Wound-Site Formation of Fibrin, a Key Component of Blood Clotting, in Healthy Volunteers Given Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. |
| 2014-11-18 | Boehringer Ingelheim | Results Interim Data Reinforce Safety and Effectiveness of Pradaxa® (dabigatran etexilate mesylate) versus Warfarin in Routine Care of Patients with Non-valvular Atrial Fibrillation prnewswire.com ↗
The data also showed a 23 percent reduction in strokes in patients taking PRADAXA compared to warfarin in this pooled analysis of both databases (HR 0.77, CI 0.54-1.09, 62 vs. 69 events). |
| 2014-11-17 | Boehringer Ingelheim | Results U.S. Department of Defense Study Supports Favorable Benefit-Risk Profile of Pradaxa® (dabigatran etexilate mesylate) for Reducing Stroke Risk in Non-valvular Atrial Fibrillation prnewswire.com ↗
The risk of major bleeding, the second primary outcome, was 13 percent less with PRADAXA (HR 0.87, CI 0.74-1.02, ER 3.08 vs. 3.70, respectively). |
| 2014-11-03 | Boehringer Ingelheim | Results FDA Study of Medicare Patients Reaffirms Safety and Efficacy Profile of Pradaxa® (dabigatran etexilate mesylate) for NVAF prnewswire.com ↗
The study found no difference in major bleeds or myocardial infarction with PRADAXA compared to warfarin. |
| 2014-09-02 | Boehringer Ingelheim | Results ESC Hot Line: Data Reports NVAF Patients Taking Pradaxa® (dabigatran etexilate mesylate) Experienced Slower Decline in Kidney Function Compared to Those on Warfarin prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a new post-hoc sub-analysis of the pivotal phase III RE-LY® trial assessing renal function change in patients with non-valvular atrial fibrillation (NVAF) treated with Pradaxa® (dabigatran etexilate mesylate) compared to warfarin. |
| 2014-04-08 | Boehringer Ingelheim | Regulatory Updated with Multimedia Content: FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism prnewswire.com ↗
This new FDA approval expands dabigatran's indications to include treatment and the reduction of the risk of recurrence of DVT and PE. |
| 2014-04-07 | Boehringer Ingelheim | Regulatory FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa ® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. |
| 2013-12-17 | Boehringer Ingelheim | Results Phase III Study of Dabigatran Etexilate Mesylate Met Primary Endpoint for Six-Month Treatment of Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) prnewswire.com ↗
In this Phase III study, published online in the American Heart Association's journal Circulation, dabigatran met the primary endpoint of non-inferiority to warfarin for recurrent, symptomatic, objectively-confirmed DVT and/or PE and related deaths during six months of treatment. |
| 2013-11-18 | Boehringer Ingelheim | Results Long-Term Data Presented at American Heart Association Scientific Sessions Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
This new analysis showed that the rates of stroke or systemic embolism for dabigatran 150 mg BID and 110 mg BID were 1.25 percent and 1.54 percent per year, respectively. |
| 2013-11-18 | Boehringer Ingelheim | Results Data from First Phase I Study of Antidote for Pradaxa® (dabigatran etexilate mesylate) Presented at American Heart Association Scientific Sessions prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results showing that its investigational fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran in healthy male volunteers. |
| 2013-10-02 | Boehringer Ingelheim | Results New Pooled Analysis Reports Pradaxa® (dabigatran etexilate mesylate) May Be Associated With Better Patient Outcomes After a Major Bleeding Event Compared to Warfarin prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a retrospective analysis comparing clinical management and patient outcomes following a major bleeding event during treatment with dabigatran or warfarin. |
| 2013-08-28 | Boehringer Ingelheim | Regulatory FDA Accepts Boehringer Ingelheim's Supplemental New Drug Application for Use of Dabigatran Etexilate Mesylate in Deep Vein Thrombosis and Pulmonary Embolism prnewswire.com ↗ |
| 2013-06-14 | Boehringer Ingelheim | Results New Long-Term Data Published in Circulation Reinforce Safety Profile of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from the RELY-ABLE ® trial, a long-term extension of the pivotal RE-LY ® study of Pradaxa ® (dabigatran etexilate mesylate) capsules in patients with non-valvular atrial fibrillation (NVAF). |
| 2013-04-30 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Pharmaceuticals, Inc. Announces Updates to Prescribing Information for Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
The PRADAXA label now carries a Boxed Warning, similar to the Boxed Warnings in the labels of other new OACs, to advise patients that discontinuing treatment puts them at increased risk of stroke. |
| 2013-03-18 | Boehringer Ingelheim | Results FDA Perspective Published in the New England Journal of Medicine Reinforces Safety of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
The FDA stated that bleeding rates associated with new use of PRADAXA do not appear to be higher than those with new use of warfarin, which is consistent with observations from the pivotal RE-LY ® trial. |
| 2013-02-20 | Boehringer Ingelheim | Results New Study Results Published in the New England Journal of Medicine Show Dabigatran Etexilate Mesylate Reduces the Risk of Recurrent Venous Thromboembolism prnewswire.com ↗
RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. |
| 2012-12-19 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Pharmaceuticals, Inc. Announces Updated Safety Information for Pradaxa® (dabigatran etexilate mesylate) Related to Prosthetic Heart Valves prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa® (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement. |
| 2012-12-08 | Boehringer Ingelheim | Results New Sub-Analyses Report Pradaxa® (dabigatran etexilate mesylate) May Be Associated With Better Patient Outcomes After a Major Bleeding Event Compared to Warfarin prnewswire.com ↗
These findings from the RE-LY® trial and four other Phase III trials report outcomes after a major bleed on dabigatran, despite the lack of a specific reversal agent, may be better than after a warfarin-associated bleed. |
| 2012-11-07 | Boehringer Ingelheim | Results Interim Results from RELY-ABLE®, the RE-LY® Extension Study, Provide Additional Clinical Evidence for the Safety of Pradaxa® (dabigatran etexilate mesylate) prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim results from the RELY-ABLE ® trial, a long-term extension of the RE-LY ® study. |
| 2012-11-04 | Boehringer Ingelheim | Results RE-LY® Sub-Analysis Suggests Similar Safety and Efficacy With Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in NVAF Patients With and Without Diabetes prnewswire.com ↗
These results are encouraging, as they indicate PRADAXA 150mg twice daily is effective in this higher risk NVAF patient population, a group in need of effective treatments," said Paul Reilly , PhD, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc. |
| 2012-06-18 | Boehringer Ingelheim | Results RE-LY Sub-Analysis Suggests Pradaxa® (dabigatran etexilate mesylate) Associated with Similar Bleeding Rates and Thromboembolic Complications in Surgery Versus Warfarin prnewswire.com ↗
In the sub-analysis, there were similar rates of bleeding between treatment groups in those undergoing urgent surgery, despite the fact that a specific reversal agent for PRADAXA is not available. |
| 2012-06-06 | Boehringer Ingelheim | Regulatory Pradaxa® (dabigatran etexilate mesylate) U.S. Label Now Affirms Superior Reduction in Ischemic and Hemorrhagic Stroke Versus Warfarin in Patients with Non-Valvular Atrial Fibrillation prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the Pradaxa® (dabigatran etexilate mesylate) capsules prescribing information has been updated to affirm that "PRADAXA 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." |
| 2012-04-18 | Boehringer Ingelheim | Results New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial prnewswire.com ↗
A new retrospective sub-analysis of the 18,113 patient RE-LY® trial showed lower rates of intracranial hemorrhage (ICH), including both fatal and traumatic ICH, for Pradaxa® (dabigatran etexilate mesylate) capsules 150mg taken twice daily compared with warfarin. |
| 2011-11-14 | Boehringer Ingelheim | Results New Subanalyses of RE-LY® Trial Evaluate PRADAXA in Subsets of Patients with Non-Valvular Atrial Fibrillation prnewswire.com ↗
A new retrospective subanalysis of the RE-LY® trial found Pradaxa® (dabigatran etexilate mesylate) capsules 150mg twice daily reduced the risk of stroke and systemic embolism compared to warfarin |
| 2011-04-04 | Boehringer Ingelheim | Results New Subanalyses of the RE-LY Trial Showed Pradaxa Reduced Stroke Risk in Patients With Varying CHA2DS2-VASc Scores and Types of Non-Valvular Atrial Fibrillation prnewswire.com ↗ |
| 2011-01-05 | Boehringer Ingelheim | Results New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion prnewswire.com ↗
Similarly, major bleeding within 30 days of cardioversion was infrequent and comparable between treatment groups (1.7%, 0.6% and 0.6%, respectively). |
| 2010-10-20 | Boehringer Ingelheim | Regulatory FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation Server Error prnewswire.com ↗
The U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib). |
| 2010-10-19 | Boehringer Ingelheim | Regulatory FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation prnewswire.com ↗
The U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib). |
| 2010-09-20 | Boehringer Ingelheim | Regulatory FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation prnewswire.com ↗
The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee today voted 9 to 0 in favor of approving dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). |
| 2010-08-29 | Boehringer Ingelheim | Results Data Published in The Lancet Compare Dabigatran Etexilate to Dose-Adjusted Warfarin Across RE-LY® Trial Centers prnewswire.com ↗
Boehringer Ingelheim today announced results from a pre-specified, retrospective, un-blinded sub-analysis of the RE-LY® trial – the largest atrial fibrillation outcomes trial ever conducted(2) – were published in The Lancet . |
All press releases naming this drug 94 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 138 sources stand behind the page.
| Field | Value | Cited 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 ↗109“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 Etexilate” NCT04695106 ↗ |
| 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 ↗ |
| Known as | BIBR 1048 MS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02170623 ↗ |
| 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 20117“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 ↗ |
| 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 ↗ |