Clinical trials: Dabigatran
Deep Vein Thrombosis, Pulmonary Embolism
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)
No randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-VTE study is a nationwide cluster randomized cross-over study comparing efficacy and safety of…
- Trial name
- DANNOAC-VTE (NCT03129555)
- Testing
- Dabigatran Etexilate Oral Capsule, Rivaroxaban Oral Tablet, Edoxaban Oral Tablet
- Where
- 26 sites in Denmark
- Volunteers
- 5,000 people
- Sponsor
- Herlev and Gentofte Hospital
Venous Thromboembolism
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm…
- Trial name
- NCT02223260
- Testing
- dabigatran
- Where
- 4 sites in Canada, France and 1 more
- Volunteers
- 8 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first…
- Trial name
- NCT02240654
- Where
- Spain
- Volunteers
- 36,573 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
- Trial name
- DaPaR (NCT05536791)
- Testing
- Dabigatran Etexilate (DE)
- Where
- 6 sites in Germany, Netherlands and 2 more
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Japanese Pradaxa PMS, Long Term
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
- Trial name
- NCT03175198
- Testing
- Prazaxa® Capsules
- Where
- Japan
- Volunteers
- 5,660 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for…
- Trial name
- NCT02631057
- Testing
- Dabigatran, Warfarin
- Where
- 2 sites in Japan
- Volunteers
- 4,313 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism, Secondary Prevention
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients.
- Trial name
- NCT02197416
- Testing
- dabigatran etexilate
- Where
- 62 sites in United States, Austria and 20 more
- Volunteers
- 214 people
- Sponsor
- Boehringer Ingelheim
Postthrombotic Syndrome
Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran
The primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin versus dabigatran).
- Trial name
- DABI-PTS (NCT03050138)
- Where
- 3 sites in Canada, Norway and 1 more
- Volunteers
- 351 people
- Sponsor
- Oslo University Hospital
Venous Thromboembolism
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
- Trial name
- NCT01773174
- Testing
- dabigatran etexilate
- Where
- 8 sites in United States
- Sponsor
- Boehringer Ingelheim
Hemorrhage
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism…
- Trial name
- NCT02815670
- Testing
- Idarucizumab
- Where
- 2 sites in Russia
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate…
- Trial name
- NCT01895777
- Testing
- dabigatran etexilate, standard of care
- Where
- 65 sites in United States, Argentina and 24 more
- Volunteers
- 267 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data
- Trial name
- NCT01083732
- Testing
- dabigatran etexilate
- Where
- 7 sites in Canada, Italy and 4 more
- Volunteers
- 18 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
Safety and Tolerability of Dabigatran Etexilate in Adolescents
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
- Trial name
- NCT00844415
- Testing
- dabigatran etexilate
- Where
- 2 sites in Canada
- Volunteers
- 9 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
- Trial name
- NCT05966740
- Where
- 10 sites in United States
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim