Venous ThromboembolismPhase 2NCT00844415

Safety and Tolerability of Dabigatran Etexilate in Adolescents

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

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 capsules in a small group of eight adolescent patients. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Venous Thromboembolism
What is being tested?: dabigatran etexilate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesCanada
Study dates: 1 Jun 2009to 1 Feb 2012
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

1160.88.00002 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.88.00001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario

Other trials in Canada

About this study

Official title: Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

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
2.14 mg/kg BID to a max 150 mg BID

Study groups in NCT00844415
Study group	Role	What they receive
dabigatran etexilate	Experimental	open label; patient to receive dabigatran etexilate BID for three days Receives: Drug: dabigatran etexilate

What is being measured

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

Number of Patients With Bleeding Events (Major and Minor)
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:
Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.
Measured: From Screening until 30 days after first drug administration (end of trial visit)
Number of Patients With Adverse Events
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
Measured: From Screening until 30 days after first drug administration (end of trial visit)
Plasma Concentration of Free Dabigatran
Plasma concentration of free dabigatran measured at 72 hours after first dose
Measured: 3 days
Plasma Concentration of Total Dabigatran
Plasma concentration of total dabigatran measured at 72 hours after first dose
Measured: Day 3
Thrombin Time (TT) Centrally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Measured: Day 3
TT Locally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Measured: Day 3

Secondary outcomes (5)

Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Measured: Day 3
aPTT Locally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Measured: Day 3
Ecarin Clotting Time (ECT)
Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
Measured: Day 3
Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Measured: Baseline and 3 days
Occurences of Clinical Outcome
Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.
Measured: 3 days

Timeline

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

1 Jun 20091 Feb 2012

First posted16 Feb 2009 (estimated)
Study start1 Jun 2009
Primary completion1 Feb 2012

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.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00844415
Sponsor's protocol ID: 1160.88
Status last verified: Jan 2025
First submitted: 13 Feb 2009
Last updated: 12 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.
PubMed 27357738

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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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
ClinicalTrials.gov ID: NCT00844415
Acronym / sponsor ID: 1160.88
Conditions: Venous Thromboembolism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Jun 2009 (actual)
Primary completion: 1 Feb 2012 (actual)
First posted: 16 Feb 2009 (estimated)
Results: Posted 26 Mar 2013

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 capsules in a small group of eight adolescent patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dabigatran etexilate	Experimental	Drug: dabigatran etexilateopen label; patient to receive dabigatran etexilate BID for three days

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

weight less than 32 kg
conditions associated with increased risk of bleeding
severe renal dysfunction or requirement for dialysis
active infective endocarditis
hepatic disease

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 etexilate2.14 mg/kg BID to a max 150 mg BID	Drug	dabigatran etexilate

Primary outcome

Number of Patients With Bleeding Events (Major and Minor)
Time frame: From Screening until 30 days after first drug administration (end of trial visit)
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds.
Number of Patients With Adverse Events
Time frame: From Screening until 30 days after first drug administration (end of trial visit)
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
Plasma Concentration of Free Dabigatran
Time frame: 3 days
Plasma concentration of free dabigatran measured at 72 hours after first dose
Plasma Concentration of Total Dabigatran
Time frame: Day 3
Plasma concentration of total dabigatran measured at 72 hours after first dose
Thrombin Time (TT) Centrally Measured
Time frame: Day 3
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
TT Locally Measured
Time frame: Day 3
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.

5 secondary outcomes

Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Time frame: Day 3
aPTT Locally Measured
Time frame: Day 3
Ecarin Clotting Time (ECT)
Time frame: Day 3
Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Time frame: Baseline and 3 days
Occurences of Clinical Outcome
Time frame: 3 days

Results and safety

Results posted to the registry on 26 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients (Pat.)	9	8

Primary outcome: Number of Patients With Bleeding Events (Major and Minor)

Time frame: From Screening until 30 days after first drug administration (end of trial visit). Number. Unit: Participants

Measure	All Patients n = 9
Value	0

Population analysed: Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Primary outcome: Number of Patients With Adverse Events

Time frame: From Screening until 30 days after first drug administration (end of trial visit). Number. Unit: Participants

Measure	All Patients n = 9
DRAEs on-treatment	2
SAEs on-treatment	0
DRAEs post-treatment	0
SAEs post-treatment	1

Population analysed: TS

Primary outcome: Plasma Concentration of Free Dabigatran

Time frame: 3 days. Geometric mean (Geometric Coefficient of Variation). Unit: ng/ml

Measure	All Patients n = 6
Patients with 75mg dose followed by 100mg (N=3)	28.0 (12.8)
Patients with 100mg dose followed by 125mg (N=3)	41.6 (66.5)

Population analysed: Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data).

Primary outcome: Plasma Concentration of Total Dabigatran

Time frame: Day 3. Geometric mean (Geometric Coefficient of Variation). Unit: ng/ml

Measure	All Patients n = 6
Patients with 75mg dose followed by 100mg (N=3)	34.2 (3.56)
Patients with 100mg dose followed by 125mg (N=3)	58.2 (48.7)

Population analysed: TS with non-sparse data

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 9 (0%)	2 of 9 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27357738Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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

2 sites in 1 country: 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 2 sites in Canada.

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 10 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 26 Mar 2013). 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?

Number of Patients With Bleeding Events (Major and Minor) (time frame: From Screening until 30 days after first drug administration (end of trial visit)). The study lists 6 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 NCT00844415, which also lists 1 linked publication.

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 12 Feb 2025.