Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
Withdrawn before enrolling · Phase 2
Conditions studied: Venous Thromboembolism
In brief
Study will assess PK/PD parameters and safety and tolerability of the study medication in this age group
Key facts
- Study ID
- NCT01773174
- Run by
- Boehringer Ingelheim
- People needed
- 0
- Starts
- 2013-01-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2015-10-26
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
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
- patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply
Where it is running
- 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
Full record on ClinicalTrials.gov
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