Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
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
1 other identifier
interventional
N/A
1 country
8
Brief Summary
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 26, 2015
October 1, 2015
2.9 years
January 18, 2013
October 23, 2015
Conditions
Outcome Measures
Primary Outcomes (10)
Ecarin clotting time (ECT)
one day
Factor IIa inhibition
one day
Incidence of all bleeding events
30 days
Incidence of all adverse events
30 days
Plasma concentrations of total dabigatran
one day
Plasma concentrations of free dabigatran
one day
Plasma concentrations of BIBR 1048 BS (Base)
one day
Plasma concentrations of BIBR 951 BS
one day
Plasma concentrations of BIBR 1087 SE (Acid)
one day
Activated prothrombin time (aPTT)
one day
Secondary Outcomes (3)
Global assessment of tolerability will be summarized across all patients in the treated set
30 days
Patient assessment of taste will be summarized across all patients in the treated set
one day
Changes in laboratory and clinical parameters
30 days
Study Arms (1)
dabigatran etexilate
EXPERIMENTALsingle dose treatment with dabigatran oral solution
Interventions
Eligibility Criteria
You may qualify if:
- males or females 1 to less than 2 years of age
- objective diagnosis of primary venous thromboembolism
- completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism
- written informed consent by parent (legal guardian) and patient assent (if applicable)
You may not qualify if:
- weight less than 9 kg
- conditions associated with increased risk of bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
1160.145.00010 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1160.145.00009 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
1160.145.00008 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
1160.145.00012 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1160.145.00007 Boehringer Ingelheim Investigational Site
Newark, New Jersey, United States
1160.145.0006 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1160.145.00001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1160.145.00011 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2013
First Posted
January 23, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 26, 2015
Record last verified: 2015-10