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

Phase 2

Withdrawn

• Conditions: Venous Thromboembolism
• Interventions: Drug: dabigatran etexilate

• Registration Number: NCT01773174
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dabigatran etexilate	dabigatran etexilate	single dose treatment with dabigatran oral solution

Primary Outcome Measures

Name	Time	Method
Incidence of all bleeding events	30 days
Plasma concentrations of total dabigatran	one day
Plasma concentrations of BIBR 1048 BS (Base)	one day
Incidence of all adverse events	30 days
Plasma concentrations of free dabigatran	one day
Plasma concentrations of BIBR 1087 SE (Acid)	one day
Ecarin clotting time (ECT)	one day
Factor IIa inhibition	one day
Plasma concentrations of BIBR 951 BS	one day
Activated prothrombin time (aPTT)	one day

Secondary Outcome Measures

Name	Time	Method
Global assessment of tolerability will be summarized across all patients in the treated set	30 days
Changes in laboratory and clinical parameters	30 days
Patient assessment of taste will be summarized across all patients in the treated set	one day

Trial Locations

Locations (8)

1160.145.00007 Boehringer Ingelheim Investigational Site; 🇺🇸 Newark, New Jersey, United States

1160.145.00010 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

1160.145.00009 Boehringer Ingelheim Investigational Site; 🇺🇸 Louisville, Kentucky, United States

1160.145.00012 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Louis, Missouri, United States

1160.145.0006 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

1160.145.00011 Boehringer Ingelheim Investigational Site; 🇺🇸 Spokane, Washington, United States

1160.145.00008 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

1160.145.00001 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States