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The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran etexilate | Other | 75mg BID by oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pradaxa, dabigatran etexilate | Drug | 75mg BID by oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose | Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough). | Immediately before the last drug administration, on day 8 |
| Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose | Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss) | 2 hours after the last drug administration, on day 8 |
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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 |
|---|---|---|---|---|---|---|
| 1160.173.002 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas | United States | |||
| 1160.173.023 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29695165 | Derived | Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate | Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fremont |
| California |
| United States |
| 1160.173.032 Boehringer Ingelheim Investigational Site | Moreno Valley | California | United States |
| 1160.173.034 Boehringer Ingelheim Investigational Site | Oceanside | California | United States |
| 1160.173.025 Boehringer Ingelheim Investigational Site | Salinas | California | United States |
| 1160.173.033 Boehringer Ingelheim Investigational Site | San Pedro | California | United States |
| 1160.173.024 Boehringer Ingelheim Investigational Site | Wilmington | Delaware | United States |
| 1160.173.010 Boehringer Ingelheim Investigational Site | Washington D.C. | District of Columbia | United States |
| 1160.173.020 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States |
| 1160.173.036 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States |
| 1160.173.012 Boehringer Ingelheim Investigational Site | Largo | Florida | United States |
| 1160.173.013 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 1160.173.005 Boehringer Ingelheim Investigational Site | Columbus | Georgia | United States |
| 1160.173.018 Boehringer Ingelheim Investigational Site | Springfield | Missouri | United States |
| 1160.173.019 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1160.173.026 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1160.173.027 Boehringer Ingelheim Investigational Site | Neptune City | New Jersey | United States |
| 1160.173.014 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina | United States |
| 1160.173.001 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | United States |
| 1160.173.008 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 1160.173.037 Boehringer Ingelheim Investigational Site | Lancaster | South Carolina | United States |
| 1160.173.030 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | United States |
| 1160.173.011 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | United States |
| 1160.173.006 Boehringer Ingelheim Investigational Site | Live Oak | Texas | United States |
| 1160.173.021 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 1160.173.035 Boehringer Ingelheim Investigational Site | Waukesha | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
Treated set (TS) which included all enrolled patients who were eligible to enter the trial, who were dispensed trial medication and were documented to have taken at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate | Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose | Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough). | Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Immediately before the last drug administration, on day 8 |
|
|
| |||||||||||||||||||||||||
| Primary | Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose | Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss) | PKS. Analysis includes patients with available data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 2 hours after the last drug administration, on day 8 |
|
|
From first drug administration until 3 days after last drug administration, up to 18 days
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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 Etexilate | Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days. | 2 | 60 | 0 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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