Safety and Tolerability of Dabigatran Etexilate in Adolescents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-01

Brief Summary

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

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dabigatran etexilate

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

Group Type EXPERIMENTAL

dabigatran etexilate

Intervention Type DRUG

2.14 mg/kg BID to a max 150 mg BID

Interventions

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dabigatran etexilate

2.14 mg/kg BID to a max 150 mg BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No