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Completed

NCT Number: NCT01083732

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada

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About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran Etexilate

Drug

Experimental dose chosen based on age and weight

Primary outcomes

  1. Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)

    Time frame: 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

    Plasma concentration of total dabigatran (SUM BIBR 953 ZW)

  2. Plasma Concentration of Free Dabigatran (BIBR 953 ZW).

    Time frame: 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

    Plasma concentration of free dabigatran (BIBR 953 ZW)

  3. Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)

    Time frame: 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

    Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).

    Some values are "NA" because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules.

  4. Plasma Concentration of Metabolite BIBR 951 BS

    Time frame: 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

    Plasma concentration of metabolite BIBR 951 BS

  5. Plasma Concentration of Metabolite BIBR 1087 SE

    Time frame: 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

    Plasma concentration of metabolite BIBR 1087 SE

  6. Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.

    Time frame: at predose and 2 and 10 h after intake of study medication.

    Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.

  7. Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.

    Time frame: at predose and 2 and 10 h after intake of study medication.

    Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation

  8. Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.

    Time frame: at predose and 2 and 10 h after intake of study medication.

    Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation

  9. Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  10. Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).

    Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  11. 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)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    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).

    Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  12. Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  13. Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).

    Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  14. 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)

    Time frame: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate

    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).

    Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

  15. Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.

    Time frame: Up to 6 days

    Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient's underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.

Secondary outcomes

  1. Percentage of Patients With Any Adverse Events During the Treatment Period

    Time frame: Up to 6 days

    Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.

  2. Global Assessment of Tolerability of Study Medication- Taste Assessment

    Time frame: Day 1 (immediately after dosing)

    The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.

  3. Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination

    Time frame: During the treatment period, Up to 6 days

    Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.

    Clinically Relevant Abnormalities for Laboratory Parameters were reported.

  4. Global Assessment of Tolerability of Study Medication

    Time frame: Day 1 (immediately after dosing)

    The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2010
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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