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

Venous Thromboembolism Clinical Trial

Official title:
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01773174
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Withdrawn
Phase Phase 2
Start date January 2013
Completion date December 2015
View Details
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