ClinicalTrials.gg
Drug

Dabigatran clinical trials

Also written Pradaxa and BIBR 1048 MS.

studies test it
147
open now
6
in phase 3
27
first study started
1998

How each study uses Dabigatran is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

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Approvals

The first approval found in each region, with its record

United States
19 Oct 2010 · PRADAXA · NDA 022512 (FDA, Drugs@FDA)
European Union
17 Mar 2008 · Pradaxa · EMEA/H/C/000829 (EMA)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Dabigatran etexilate
51
Dabigatran
47
Dabigatran Etexilate 150mg
4
Dabigatran Etexilate Mesylate
3
Pradax (Canada)/ Pradaxa (USA and rest of world)
2

Brand

Pradaxa
35

Development codes

BIBR 1048 MS
7
SUB20521
1

Studies by the year they started

147 studies that test it; most in 2013 (11)

Studies that test Dabigatran, by start year
YearStudies
19981
19993
20002
20013
20025
20033
20045
20054
20066
20072
20085
20097
20104
20119
20128
201311
201411
20157
201610
20178
20186
20195
20206
20214
20226
20243
20252
20261

By phase

A phase 1/2 study counts in both.

Early Phase 1
1
Phase 1
56
Phase 2
22
Phase 3
27
Phase 4
35
No phase
8

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Who runs them

Industry 78 · Other 69

Boehringer Ingelheim (66) · Pfizer (3) · The University of Hong Kong (2) · Vanderbilt University Medical Center (2) · Imperial College London (2) · University of Sao Paulo General Hospital (2) · Merck Sharp & Dohme LLC (2) · University of Alberta (2)

Often tested with

Tested in the same studies.

Rivaroxaban (21) · Apixaban (13) · Edoxaban (8) · Warfarin (7) · Midazolam (3) · Rosuvastatin (3) · Enoxaparin (3) · Pantoprazole (3)

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Reaching primary completion within a year · 1

Studies that test Dabigatran.

Studies

Open first, then newest update. How each study uses Dabigatran is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 147

See all 147 studies that test Dabigatran →

Given beside what is tested · 20 — Dabigatran is usual care or a partner of the new treatment
As the comparator · 6 — what is tested is compared with Dabigatran

Codes

What other systems call Dabigatran · ClinicalTrials.gg INT006619

  • MeSH (NLM) D000069604DabigatranConfirmed ClinicalTrials.gov, NLM, Wikidata
  • UNII (FDA) I0VM4M70GCDABIGATRANConfirmed FDA, NLM, Wikidata
  • RxNorm 1546356Confirmed FDA, Wikidata
  • Wikidata Q419345dabigatranConfirmed FDA, NLM, Wikidata
  • NCI Thesaurus C73224DabigatranOne source FDA
  • DrugBank DB14726One source Wikidata

Also registered as dabigatran etexilate (UNII 2E18WX195X · RxNorm 1037042) and dabigatran etexilate mesylate (UNII SC7NUW5IIT · RxNorm 1037041).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.