Venous ThromboembolismPhase 2NCT01083732

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

A Phase 2 study testing dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 7 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data Read more about this study

Who is it for?: Ages 1 year to 11 years
Conditions the study is for: Venous Thromboembolism
What is being tested?: dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 7 sitesin 6 countries
Study dates: Mar 2010to Feb 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

7 sites in 6 countries.

Country

City, postcode or hospital

7 sites in 6 countries

Thailand2 sites

Boehringer Ingelheim Investigational Site
Bangkok
Boehringer Ingelheim Investigational Site
Khon Kaen

Other trials in Thailand

Canada1 site

Boehringer Ingelheim Investigational Site
Ottawa, Ontario

Other trials in Canada

Italy1 site

Boehringer Ingelheim Investigational Site
Roma

Other trials in Italy

Lithuania1 site

Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

Russia1 site

Boehringer Ingelheim Investigational Site
Kazan'

Other trials in Russia

Switzerland1 site

Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

About this study

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

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

Read the detailed description

Purpose:

Conditions: Venous Thromboembolism
Being tested: dabigatran etexilate
Medical subject headings: Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dabigatran etexilateDrug
Experimental dose chosen based on age and weight

Study groups in NCT01083732
Study group	Role	What they receive
dabigatran etexilate	Experimental	treatment with dabigatran oral solution as a single dose Receives: Drug: dabigatran etexilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
Plasma concentration of total dabigatran (SUM BIBR 953 ZW)
Measured: 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).
Plasma concentration of free dabigatran (BIBR 953 ZW)
Measured: 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)
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.
Measured: 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
Plasma concentration of metabolite BIBR 951 BS
Measured: 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
Plasma concentration of metabolite BIBR 1087 SE
Measured: 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
Central Measurement of Activated Partial Thromboplastin Time (aPTT) 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.
Measured: at predose and 2 and 10 h after intake of study medication.
Central Measurement of Ecarin Clotting Time (ECT) 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
Measured: at predose and 2 and 10 h after intake of study medication.
Central Measurement of Diluted Thrombin Time (dTT) 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
Measured: at predose and 2 and 10 h after intake of study medication.
Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.
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.
Measured: Up to 6 days

Secondary outcomes (4)

Percentage of Patients With Any Adverse Events During the Treatment Period
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.
Measured: Up to 6 days
Global Assessment of Tolerability of Study Medication- Taste Assessment
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.
Measured: Day 1 (immediately after dosing)
Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination
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.
Measured: During the treatment period, Up to 6 days
Global Assessment of Tolerability of Study Medication
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).
Measured: Day 1 (immediately after dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Feb 2016

First posted10 Mar 2010 (estimated)
Study startMar 2010
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083732
Sponsor's protocol ID: 1160.89
Other IDs: 2009-013618-29, 2009
Status last verified: Nov 2016
First submitted: 8 Mar 2010
Last updated: 28 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01083732
Acronym / sponsor ID: 1160.89
Conditions: Venous Thromboembolism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 10 Mar 2010 (estimated)
Results: Posted 28 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Purpose:

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dabigatran etexilate	Experimental	Drug: dabigatran etexilatetreatment with dabigatran oral solution as a single dose

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran etexilateExperimental dose chosen based on age and weight	Drug	dabigatran etexilate

Primary outcome

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)
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)
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.
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
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
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.
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
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
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).
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).
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).
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).
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).
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).
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.

4 secondary outcomes

Percentage of Patients With Any Adverse Events During the Treatment Period
Time frame: Up to 6 days
Global Assessment of Tolerability of Study Medication- Taste Assessment
Time frame: Day 1 (immediately after dosing)
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
Global Assessment of Tolerability of Study Medication
Time frame: Day 1 (immediately after dosing)

Results and safety

Results posted to the registry on 28 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):	6	6
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)	9	9
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)	3	3

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) n = 6	Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) n = 9	Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) n = 3
1h (N= 4, 9, NA)	79.4 (45.6)	90.6 (48.8)	NA (NA)
2h (N=6, 9, 2)	129.0 (9.84)	114.0 (37.9)	26.0 (62.6)
4h (N=6, 9, NA)	91.0 (23.0)	87.7 (31.6)	NA (NA)
6h (N=6, 9, NA)	62.9 (32.6)	56.2 (34.2)	NA (NA)
10h (N=6, 9, NA)	34.8 (41.4)	28.2 (37.0)	NA (NA)
50h (N=NA, NA, 2)	NA (NA)	NA (NA)	46.0 (64.7)
72h (N=NA, NA, 3)	NA (NA)	NA (NA)	11.9 (47.8)

Population analysed: Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints. PKS (evaluable cases)

Primary outcome: Plasma Concentration of Free Dabigatran (BIBR 953 ZW).

Measure	Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) n = 6	Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) n = 9	Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) n = 3
1h (N= 4, 9, NA)	68.5 (43.8)	80.0 (43.9)	NA (NA)
2h (N=6, 9, 2)	101.0 (12.8)	98.5 (35.3)	23.4 (72.2)
4h (N=6, 9, NA)	75.3 (30.2)	74.5 (31.7)	NA (NA)
6h (N=6, 9, NA)	51.6 (40.0)	48.4 (37.9)	NA (NA)
10h (N=6, 9, NA)	28.1 (49.8)	23.7 (40.3)	NA (NA)
50h (N=NA, NA, 2)	NA (NA)	NA (NA)	37.3 (60.7)
72h (N=NA, NA, 3)	NA (NA)	NA (NA)	8.43 (44.0)

Population analysed: PKS (evaluable cases)

Primary outcome: Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)

Measure	Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years) n = 15	Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) n = 3
1h (N= 13, NA)	3.82 (107)	NA (NA)
2h (N=5, 2)	3.23 (74.4)	NA (NA)
4h (N=15, NA)	NA (NA)	NA (NA)
6h (N=1, NA)	1.05 (NA)	NA (NA)
10h (N=15, NA)	NA (NA)	NA (NA)
50h (N=NA, 2)	NA (NA)	NA (NA)
72h (N=NA, 3)	NA (NA)	NA (NA)

Population analysed: PKS (evaluable cases)

Primary outcome: Plasma Concentration of Metabolite BIBR 951 BS

Measure	Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years) n = 15	Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) n = 3
1h (N=13, NA)	4.88 (82.2)	NA (NA)
2h (N=15, 2)	3.55 (83.0)	NA (NA)
4h (N=4, NA)	1.71 (52.8)	NA (NA)
6h (N=15, NA)	NA (NA)	NA (NA)
10h (N=15, NA)	NA (NA)	NA (NA)
50h (N=NA, 2)	NA (NA)	NA (NA)
72h (N=NA, 3)	NA (NA)	NA (NA)

Population analysed: PKS (evaluable cases)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events (AEs) during the treatment period, up to 6 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)	0 of 6 (0%)	0 of 6 (0%)	Not reported
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)	0 of 9 (0%)	0 of 9 (0%)	Not reported
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

7 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 7 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Thailand, Canada, Italy, Lithuania, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01083732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.