Safety and Tolerability of Dabigatran Etexilate in Adolescents
- Registration Number
- NCT00844415
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dabigatran etexilate dabigatran etexilate open label; patient to receive dabigatran etexilate BID for three days
- Primary Outcome Measures
Name Time Method Number of Patients With Bleeding Events (Major and Minor) 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 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 3 days Plasma concentration of free dabigatran measured at 72 hours after first dose
Plasma Concentration of Total Dabigatran Day 3 Plasma concentration of total dabigatran measured at 72 hours after first dose
Thrombin Time (TT) Centrally Measured Day 3 Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
TT Locally Measured Day 3 Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
- Secondary Outcome Measures
Name Time Method Activated Partial Thromboplastin Time (aPTT) Centrally Measured Day 3 Measurement of aPTT was performed locally and centrally using validated assays.
aPTT Locally Measured Day 3 Measurement of aPTT was performed locally and centrally using validated assays.
Ecarin Clotting Time (ECT) 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 Baseline and 3 days Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Occurences of Clinical Outcome 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.
Trial Locations
- Locations (2)
1160.88.00002 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1160.88.00001 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada