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Trial record 57 of 333 for:    DABIGATRAN

Safety and Tolerability of Dabigatran Etexilate in Adolescents

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ClinicalTrials.gov Identifier: NCT00844415
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : March 26, 2013
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Venous Thromboembolism
Intervention Drug: dabigatran etexilate
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients (Pat.)
Hide Arm/Group Description Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Period Title: Overall Study
Started 9 [1]
Pat. Received 75mg Followed by 100mg 3
Pat. Received 100mg Followed by 125mg 3
Pat. Received 125mg Followed by 150mg 2
Pat. Received Single Dose 75mg 1
Completed 8 [2]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Entered and treated.
[2]
Completed.
Arm/Group Title All Patients
Hide Arm/Group Description Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
15.7  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
1.Primary Outcome
Title Number of Patients With Bleeding Events (Major and Minor)
Hide Description

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.

Time Frame From Screening until 30 days after first drug administration (end of trial visit)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
0
2.Primary Outcome
Title Number of Patients With Adverse Events
Hide Description 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.
Time Frame From Screening until 30 days after first drug administration (end of trial visit)
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
DRAEs on-treatment 2
SAEs on-treatment 0
DRAEs post-treatment 0
SAEs post-treatment 1
3.Primary Outcome
Title Plasma Concentration of Free Dabigatran
Hide Description Plasma concentration of free dabigatran measured at 72 hours after first dose
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/ml
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%)
4.Primary Outcome
Title Plasma Concentration of Total Dabigatran
Hide Description Plasma concentration of total dabigatran measured at 72 hours after first dose
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/ml
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%)
5.Primary Outcome
Title Thrombin Time (TT) Centrally Measured
Hide Description Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Patients with 75mg dose followed by 100mg (N=3) 36.9  (3.61)
Patients with 100mg dose followed by 125mg (N=3) 37.4  (3.97)
6.Primary Outcome
Title TT Locally Measured
Hide Description Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Patients with 75mg dose followed by 100mg (N=3) 33.5  (2.15)
Patients with 100mg dose followed by 125mg (N=3) 36.8  (5.72)
7.Secondary Outcome
Title Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Hide Description Measurement of aPTT was performed locally and centrally using validated assays.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Patients with 75mg dose followed by 100mg (N=3) 38.6  (2.94)
Patients with 100mg dose followed by 125mg (N=3) 47.4  (4.42)
8.Secondary Outcome
Title aPTT Locally Measured
Hide Description Measurement of aPTT was performed locally and centrally using validated assays.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Patients with 75mg dose followed by 100mg (N=3) 29.9  (2.68)
Patients with 100mg dose followed by 125mg (N=3) 33.6  (0.896)
9.Secondary Outcome
Title Ecarin Clotting Time (ECT)
Hide Description Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-sparse data
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: seconds
Patients with 75mg dose followed by 100mg (N=3) 43.3  (1.31)
Patients with 100mg dose followed by 125mg (N=3) 49.6  (11.6)
10.Secondary Outcome
Title Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
Hide Description Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
Time Frame Baseline and 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
0
11.Secondary Outcome
Title Occurences of Clinical Outcome
Hide Description 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.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title All Patients
Hide Arm/Group Description:
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
Patients with recurrent VTE 1
Patients with PTS 0
Patients with PE 0
Patients with VTE related death 0
Patients with other death 0
Patients with other clinical outcome 0
Time Frame 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   2/9 (22.22%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/9 (11.11%) 
Abdominal pain  1  1/9 (11.11%) 
Gastrooesophageal reflux disease  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00844415     History of Changes
Other Study ID Numbers: 1160.88
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: February 13, 2013
Results First Posted: March 26, 2013
Last Update Posted: June 9, 2014