Phase 2
Completed N=18
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Source: ClinicalTrials.gov NCT01083732 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW) — 79.4; 90.6; NA; 129.0 ng/mL
Summary
To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW) |
79.4; 90.6; NA; 129.0; 114.0; 26.0 | — |
| PRIMARY Plasma Concentration of Free Dabigatran (BIBR 953 ZW). |
68.5; 80.0; NA; 101.0; 98.5; 23.4 | — |
| PRIMARY Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS) |
3.82; NA; 3.23; NA; NA; NA | — |
| PRIMARY Plasma Concentration of Metabolite BIBR 951 BS |
4.88; NA; 3.55; NA; 1.71; NA | — |
| PRIMARY Plasma Concentration of Metabolite BIBR 1087 SE |
2.31; NA; 1.51; NA; 1.18; NA | — |
| PRIMARY Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication. |
32.3; 34.9; 47.5; 77.0; 40.3; 58.4 | — |
| PRIMARY Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication. |
36.9; 36.8; 79.8; 73.6; 49.7; 52.2 | — |
| PRIMARY Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication. |
31.9; 35.6; 32.9; 46.6; 53.6; 34.3 | — |
| PRIMARY Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma) |
129; 116 | — |
| PRIMARY Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma) |
1.99; 2.00 | — |
| PRIMARY AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point) |
715; 658 | — |
| PRIMARY Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma) |
101; 102 | — |
| PRIMARY Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma) |
1.99; 2.00 | — |
| PRIMARY AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point) |
581; 566 | — |
| PRIMARY Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period. |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Patients With Any Adverse Events During the Treatment Period |
0.0; 0.0; 33.3 | — |
| SECONDARY Global Assessment of Tolerability of Study Medication- Taste Assessment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination |
0.0; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Tolerability of Study Medication |
33.33; 11.11; 100.00; 16.67; 22.22; 0 | — |
Eligibility Criteria
Inclusion criteria
- males or females 1 to less than 12 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 (if applicable)
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01083732). 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.