Phase 2
Completed N=9
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Source: ClinicalTrials.gov NCT00844415 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Number of Patients With Bleeding Events (Major and Minor) — 0 Participants
Summary
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Bleeding Events (Major and Minor) |
— | — |
| PRIMARY Number of Patients With Adverse Events |
2; 0; 0; 1 | — |
| PRIMARY Plasma Concentration of Free Dabigatran |
28.0; 41.6 | — |
| PRIMARY Plasma Concentration of Total Dabigatran |
34.2; 58.2 | — |
| PRIMARY Thrombin Time (TT) Centrally Measured |
36.9; 37.4 | — |
| PRIMARY TT Locally Measured |
33.5; 36.8 | — |
| SECONDARY Activated Partial Thromboplastin Time (aPTT) Centrally Measured |
38.6; 47.4 | — |
| SECONDARY aPTT Locally Measured |
29.9; 33.6 | — |
| SECONDARY Ecarin Clotting Time (ECT) |
43.3; 49.6 | — |
| SECONDARY Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs |
— | — |
| SECONDARY Occurences of Clinical Outcome |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- males or females 12 to less than 18 years of age
- objective diagnosis of primary VTE
- completion of planned treatment course with LMWH or OAC for primary VTE
- written informed consent by parent (legal guardian) and patient assent
Exclusion criteria
- weight less than 32 kg
- conditions associated with increased risk of bleeding
- severe renal dysfunction or requirement for dialysis
- active infective endocarditis
- hepatic disease
- pregnant females or females not using medically accepted contraceptive method
- anemia or thrombocytopenia
- use of prohibited or restricted drug within previous week
- received investigational drug within past 30 days
- unreliable patients or patients who have any condition that would not allow safe participation in study
Data sourced from ClinicalTrials.gov (NCT00844415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.