ClinicalTrials.Veeva

Menu

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 2

Conditions

Venous Thromboembolism

Treatments

Drug: dabigatran etexilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083732
2009-013618-29 (EudraCT Number)
1160.89

Details and patient eligibility

About

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Full description

Purpose:

Enrollment

18 patients

Sex

All

Ages

1 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. males or females 1 to less than 12 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 (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

18 participants in 1 patient group

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

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems