Clinical trial NCT01083732: Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Official title: Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

1. males or females 1 to less than 12 years of age
2. objective diagnosis of primary VTE
3. completion of planned treatment course with LMWH or OAC for primary VTE
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

Primary outcomes:
measure: Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
measure: Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
measure: Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
measure: Plasma Concentration of Metabolite BIBR 951 BS
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
measure: Plasma Concentration of Metabolite BIBR 1087 SE
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
measure: Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
timeFrame: at predose and 2 and 10 h after intake of study medication.
measure: Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
timeFrame: at predose and 2 and 10 h after intake of study medication.
measure: Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
timeFrame: at predose and 2 and 10 h after intake of study medication.
measure: Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: 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)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: 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)
timeFrame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
measure: Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.
timeFrame: Up to 6 days
Secondary outcomes:
measure: Percentage of Patients With Any Adverse Events During the Treatment Period
timeFrame: Up to 6 days
measure: Global Assessment of Tolerability of Study Medication- Taste Assessment
timeFrame: Day 1 (immediately after dosing)
measure: Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination
timeFrame: During the treatment period, Up to 6 days
measure: Global Assessment of Tolerability of Study Medication
timeFrame: Day 1 (immediately after dosing)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Roma
country: Italy
facility: Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Zürich
country: Switzerland
facility: Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: Boehringer Ingelheim Investigational Site
city: Khon Kaen
country: Thailand
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: