Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
| Status: | Withdrawn |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 1 - 2 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | December 2015 |
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
Study will assess PK/PD parameters and safety and tolerability of the study medication in
this age group
this age group
Inclusion criteria:
1. males or females 1 to less than 2 years of age
2. objective diagnosis of primary venous thromboembolism
3. completion of planned treatment course with low molecular weight heparin or oral
anticoagulant for primary venous thromboembolism
4. written informed consent by parent (legal guardian) and patient assent (if
applicable)
Exclusion criteria:
1. weight less than 9 kg
2. conditions associated with increased risk of bleeding
3. patients who have any condition that would not allow safe participation in study
Note: Further exclusion criteria apply
We found this trial at
8
sites
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