Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/29/2015 |
| Start Date: | September 2014 |
| End Date: | April 2016 |
| Contact: | Boehringer Ingelheim Call Center |
| Email: | clintriage.rdg@boehringer-ingelheim.com |
| Phone: | 1-800-243-0127 |
Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate
solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to
older children and adults and to confirm dabigatran etexilate dosing algorithm for children
aged less than 1 year.
solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to
older children and adults and to confirm dabigatran etexilate dosing algorithm for children
aged less than 1 year.
Purpose:
Inclusion criteria:
- Neonates and infants with aged < 12 months at Visit 1
- Objective diagnosis of VTE
- End of planned treatment course with anticoagulant therapy as per standard of care at
the investigator site.
- Written informed consent provided by the patient's parent(s) (or legal guardian)
according to local regulations at Visit 1.
Exclusion criteria:
- Weight less than 3 kg at Visit 1
- Conditions associated with an increased risk of bleeding
- renal dysfunction
- hepatic disease
- Anemia or thrombocytopenia at screening
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