Trial · NCT02223260
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
NCT02223260, Phase 2, Completed, Boehringer Ingelheim; results first posted 2016-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age. Trials, record NCT02223260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02223260
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
- NCT number
- NCT02223260
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Venous Thromboembolism
- Interventions
- dabigatran
- First posted
- 2014-08-22
- Last updated
- 2016-09-20
- Other registries' IDs
- eudract:2014-001259-22
- Results first posted
- 2016-09-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate | 2 hours (h) and 12h after drug administration on day 1 | Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate. |
| Primary | Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | 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. |
| Primary | Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | 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. |
| Primary | Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | 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. |
| Primary | Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
| Primary | Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
| Primary | Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
| Secondary | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
| Secondary | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
| Secondary | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate | 2 hours (h) and 12h after drug administration on day 1 | 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. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | PKS | second | MEAN |
| PRIMARY | Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | PKS | second | MEAN |
| PRIMARY | Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | 2 h, and 12 h after dosing on day 1 | PKS | second | MEAN |
| PRIMARY | Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | ratio | MEAN |
| PRIMARY | Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | Ratio | MEAN |
| PRIMARY | Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | ratio | MEAN |
| SECONDARY | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | R-Square | NUMBER |
| SECONDARY | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | R-Square | NUMBER |
| SECONDARY | PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values. | baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1 | PKS | R-Square | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate | Dabigatran Etexilate | 2h | 120.0 | Geometric Coefficient of Variation 62.1 | ng/mL |
| Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate | Dabigatran Etexilate | 12h | 60.4 | Geometric Coefficient of Variation 30.0 | ng/mL |
| Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E2 | 78.9 | Standard Deviation 26.7 | second |
| Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E12 | 62.8 | Standard Deviation 27.7 | second |
| Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E2 | 101 | Standard Deviation 44.3 | second |
| Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E12 | 66.9 | Standard Deviation 23.5 | second |
| Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E2 | 48.7 | Standard Deviation 24 | second |
| Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | E12 | 38.6 | Standard Deviation 8.12 | second |
| Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | ER2 | 1.86 | Standard Deviation 19.5 | ratio |
| Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate. | Dabigatran Etexilate | ER12 | 1.47 | Standard Deviation 17.7 | ratio |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran Etexilate | 8 | |
| Overall Study | COMPLETED | Dabigatran Etexilate | 8 | |
| Overall Study | NOT COMPLETED | Dabigatran Etexilate | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran Etexilate | ||
| Total, other adverse events | Dabigatran Etexilate | 0 | 8 |
| Total, serious adverse events | Dabigatran Etexilate | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02223260
GET https://conductscience.org/api/trials/v1/NCT02223260/results?page=2