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Trial record 20 of 333 for:    DABIGATRAN

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

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ClinicalTrials.gov Identifier: NCT02223260
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Venous Thromboembolism
Intervention Drug: dabigatran
Enrollment 8
Recruitment Details  
Pre-assignment Details This was an open-label, multicentre, multinational, non-randomised, uncontrolled, single dose, single arm Phase IIa study.
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
Treated set (TS): the treated set included 8 patients who were dispensed study medication and were documented to have taken at least 1 dose of trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 8 participants
2.912  (1.694)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
1.Primary Outcome
Title Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate
Hide Description Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.
Time Frame 2 hours (h) and 12h after drug administration on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least 1 PK/PD observation and had no important Protocol violations (PVs) with respect to statistical analysis of Pharmacokinetic (PK) or Pharmacodynamic (PD ) endpoints.
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2h
120.0
(62.1%)
12h
60.4
(30.0%)
2.Primary Outcome
Title Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Time Frame 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: second
E2 78.9  (26.7)
E12 62.8  (27.7)
3.Primary Outcome
Title Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Time Frame 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: second
E2 101  (44.3)
E12 66.9  (23.5)
4.Primary Outcome
Title Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.
Time Frame 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: second
E2 48.7  (24)
E12 38.6  (8.12)
5.Primary Outcome
Title Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description

Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented.

Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ratio
ER2 1.86  (19.5)
ER12 1.47  (17.7)
6.Primary Outcome
Title Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description

Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented.

Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Ratio
ER2 2.42  (34.2)
ER12 1.63  (13.8)
7.Primary Outcome
Title Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.
Hide Description

Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.

dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented.

Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ratio
ER2 1.59  (25.4)
ER12 1.26  (5.67)
8.Secondary Outcome
Title PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.
Hide Description Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.
Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: R-Square
0.752
9.Secondary Outcome
Title PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.
Hide Description Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.
Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: R-Square
0.858
10.Secondary Outcome
Title PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.
Hide Description Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.
Time Frame baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: R-Square
0.920
11.Secondary Outcome
Title Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.
Hide Description

Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:

Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding.

Time Frame Within two days after the administration of trial medication, up to 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Percentage of participants
0.0
12.Secondary Outcome
Title Incidence of All AEs During the Treatment Period
Hide Description Percentage of patients with all adverse events (AEs) during the treatment period (including REP).
Time Frame Within two days after the administration of trial medication, up to 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
0.0
13.Secondary Outcome
Title Global Assessment of Acceptability and Tolerability of Study Medication
Hide Description The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).
Time Frame Day 1 (immediately after dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description:
The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
Good 75.0
Satisfactory 12.5
Not satisfactory 0.0
Bad 12.5
Not assessable 0.0
Time Frame Within two days after the administration of trial medication, up to 3 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate
Hide Arm/Group Description The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
All-Cause Mortality
Dabigatran Etexilate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate
Affected / at Risk (%)
Total   0/8 (0.00%) 
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02223260     History of Changes
Other Study ID Numbers: 1160.105
2014-001259-22 ( EudraCT Number: EudraCT )
First Submitted: August 21, 2014
First Posted: August 22, 2014
Results First Submitted: July 28, 2016
Results First Posted: September 20, 2016
Last Update Posted: September 20, 2016