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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021819-16 | EudraCT Number | EudraCT |
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The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate 110 mg | Experimental | Capsule, oral |
|
| Dabigatran etexilate 75 mg | Experimental | Capsule, oral |
|
| Dabigatran etexilate 150 mg | Experimental | Capsule, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug | 150 mg capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis Clearance of Dabigatran | Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma. | 4 hours |
| Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis | Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage. | 4 hours |
| Plasma Concentration Extraction Ratio | Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction). | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h) | Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran. | Days 2 and 3 |
| Maximum Plasma Concentrations of Dabigatran (Cmax) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.121.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
This was an open-label, 2-period, fixed-sequence, multiple dose trial. On Day 1, all patients were treated with Dabigatran 150 mg, on day 2, with 110 mg at 10:00, and on day 3, 75 mg 8 h before dialysis. The target blood flow rate on day 3 of period 1 was 200mL/min, whilst that in period 2 was 400mL/min.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
Treated set (TS) included all 7 subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Dabigatran treated patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dialysis Clearance of Dabigatran | Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma. | Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 4 hours |
|
2 periods of 5 days each
Before and after dialysis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran | Dabigatran treated patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Dabigatran etexilate |
| Drug |
75 mg capsule |
|
| Dabigatran etexilate | Drug | 110 mg capsule |
|
Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran. |
| Days 2 and 3 |
| Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran. | Day 3 |
| Coagulation Parameters | Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds. | Day 3 |
| Safety and Tolerability | Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment. | 2 periods of 5 days each |
| Additional Safety Parameters | By study design abnormalities could be due to dialysis or Dabigatran. | 2 periods of 5 days each |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Period 2 target blood flow rate during dialysis was 400mL/min |
|
|
| Primary | Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis | Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 4 hours |
|
|
|
| Primary | Plasma Concentration Extraction Ratio | Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | 4 hours |
|
|
|
| Secondary | Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h) | Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran. | Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Days 2 and 3 |
|
|
|
| Secondary | Maximum Plasma Concentrations of Dabigatran (Cmax) | Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 2 and 3 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Day 3 |
|
|
|
| Secondary | Coagulation Parameters | Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds. | TS | Posted | Mean | Standard Deviation | sec | Day 3 |
|
|
|
| Secondary | Safety and Tolerability | Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment. | TS | Posted | Number | Participants | 2 periods of 5 days each |
|
|
|
| Secondary | Additional Safety Parameters | By study design abnormalities could be due to dialysis or Dabigatran. | TS | Posted | Number | Participants | 2 periods of 5 days each |
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Free Dabigatran on Day 2 |
|
| Free Dabigatran on Day 3 |
|
| Free Dabigatran on Day 2 |
|
| Free Dabigatran on Day 3 |
|
|
| Laboratory abnormalities: Haematology |
|
| Laboratory abnormalities: Clinical chemistry |
|