Status:
COMPLETED
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- males or females 12 to less than 18 years of age
- objective diagnosis of primary VTE
- completion of planned treatment course with LMWH or OAC for primary VTE
- written informed consent by parent (legal guardian) and patient assent
- Exclusion criteria:
- weight less than 32 kg
- conditions associated with increased risk of bleeding
- severe renal dysfunction or requirement for dialysis
- active infective endocarditis
- hepatic disease
- pregnant females or females not using medically accepted contraceptive method
- anemia or thrombocytopenia
- use of prohibited or restricted drug within previous week
- received investigational drug within past 30 days
- unreliable patients or patients who have any condition that would not allow safe participation in study
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00844415
Start Date
June 1 2009
Last Update
February 12 2025
Active Locations (2)
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1
1160.88.00002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
2
1160.88.00001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada