Safety and Tolerability of Dabigatran Etexilate in Adolescents
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years|
- Number of Patients With Bleeding Events (Major and Minor) [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ]
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:
Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.
- Number of Patients With Adverse Events [ Time Frame: From Screening until 30 days after first drug administration (end of trial visit) ]Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
- Plasma Concentration of Free Dabigatran [ Time Frame: 3 days ]Plasma concentration of free dabigatran measured at 72 hours after first dose
- Plasma Concentration of Total Dabigatran [ Time Frame: Day 3 ]Plasma concentration of total dabigatran measured at 72 hours after first dose
- Thrombin Time (TT) Centrally Measured [ Time Frame: Day 3 ]Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
- TT Locally Measured [ Time Frame: Day 3 ]Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
- Activated Partial Thromboplastin Time (aPTT) Centrally Measured [ Time Frame: Day 3 ]Measurement of aPTT was performed locally and centrally using validated assays.
- aPTT Locally Measured [ Time Frame: Day 3 ]Measurement of aPTT was performed locally and centrally using validated assays.
- Ecarin Clotting Time (ECT) [ Time Frame: Day 3 ]Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
- Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs [ Time Frame: Baseline and 3 days ]Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
- Occurences of Clinical Outcome [ Time Frame: 3 days ]Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.
|Study Start Date:||June 2009|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
Drug: dabigatran etexilate
2.14 mg/kg BID to a max 150 mg BID
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844415
|1160.88.00002 Boehringer Ingelheim Investigational Site|
|Edmonton, Alberta, Canada|
|1160.88.00001 Boehringer Ingelheim Investigational Site|
|Ottawa, Ontario, Canada|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|