Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
NCT ID: NCT01083732
Last Updated: 2016-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2010-03-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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dabigatran etexilate
treatment with dabigatran oral solution as a single dose
dabigatran etexilate
Experimental dose chosen based on age and weight
Interventions
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dabigatran etexilate
Experimental dose chosen based on age and weight
Eligibility Criteria
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Inclusion Criteria
2. objective diagnosis of primary VTE
3. completion of planned treatment course with LMWH or OAC for primary VTE
4. written informed consent by parent (legal guardian) and patient assent (if applicable)
Exclusion Criteria
2. conditions associated with increased risk of bleeding
1 Year
11 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Boehringer Ingelheim Investigational Site
Roma, , Italy
Boehringer Ingelheim Investigational Site
Vilnius, , Lithuania
Boehringer Ingelheim Investigational Site
Kazan', , Russia
Boehringer Ingelheim Investigational Site
Zurich, , Switzerland
Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
Boehringer Ingelheim Investigational Site
Khon Kaen, , Thailand
Countries
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Other Identifiers
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2009-013618-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1160.89
Identifier Type: -
Identifier Source: org_study_id