Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

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Boehringer Ingelheim

Status and phase

Withdrawn
Phase 2

Conditions

Venous Thromboembolism

Treatments

Drug: dabigatran etexilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01773174
1160.145

Details and patient eligibility

About

Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group

Sex

All

Ages

1 to 2 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. males or females 1 to less than 2 years of age
  2. objective diagnosis of primary venous thromboembolism
  3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
  4. written informed consent by parent (legal guardian) and patient assent (if applicable)

Exclusion criteria

  1. weight less than 9 kg
  2. conditions associated with increased risk of bleeding
  3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

dabigatran etexilate
Experimental group
Description:
single dose treatment with dabigatran oral solution
Treatment:
Drug: dabigatran etexilate

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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