Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
NCT01773174 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2015-10-26
Summary
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
dabigatran etexilate
age \& weight adjusted equivalent of adult dose
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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