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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003081-32 | EudraCT Number | EudraCT |
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The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran Etexilate | Experimental | patient to receive a capsule containing 75 mg of dabigatran etexilate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran Etexilate | Drug | Dabigatran Etexilate 75mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | Maximum concentration of Dabigatran etexilate in plasma at steady state was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration. | -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h |
| AUCtau,ss | Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration. | -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h |
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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 |
|---|---|---|---|---|---|---|
| 1160.166.31001 Boehringer Ingelheim Investigational Site | Leiden | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran 75 mg | Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS) which included all patients who had taken at least 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran 75 mg | Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily |
| 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 | Cmax,ss | Maximum concentration of Dabigatran etexilate in plasma at steady state was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration. | Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h |
|
Up to Day 11
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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 75 mg | Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | 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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | AUCtau,ss | Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h |
|
|
|
|
| 0 |
| 16 |
| 6 |
| 16 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
|
| Nail injury | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MEDDRA 17.0 | Systematic Assessment |
|
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
| 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 |
Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: > median age). Median is calculated based on trial data of treated set |
| ANOVA |
ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'. |
| 0.9734 |
| 2-Sided |
| No |
| Superiority or Other |
| Patients were classified based on the gender distribution. | ANOVA | ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'. | 0.9201 | 2-Sided | No | Superiority or Other |