Safety and Tolerability of Dabigatran Etexilate in Adolescents

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00844415

1160.88

Details and patient eligibility

About

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

Enrollment: 9 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. males or females 12 to less than 18 years of age
2. objective diagnosis of primary VTE
3. completion of planned treatment course with LMWH or OAC for primary VTE
4. written informed consent by parent (legal guardian) and patient assent

Exclusion criteria

1. weight less than 32 kg
2. conditions associated with increased risk of bleeding
3. severe renal dysfunction or requirement for dialysis
4. active infective endocarditis
5. hepatic disease
6. pregnant females or females not using medically accepted contraceptive method
7. anemia or thrombocytopenia
8. use of prohibited or restricted drug within previous week
9. received investigational drug within past 30 days
10. unreliable patients or patients who have any condition that would not allow safe participation in study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

dabigatran etexilate

Experimental group

Description:

open label; patient to receive dabigatran etexilate BID for three days

Treatment:

Drug: dabigatran etexilate