Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Public ClinicalTrials.gov record NCT01896297. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01896297
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2013 (Type not available)
- Primary completion
- Oct 2015 (Actual)
- Completion
- Oct 2015 (Actual)
- Last update posted
- Nov 30, 2016
2013 – 2015
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1160.173.002 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas | — | — |
| 1160.173.023 Boehringer Ingelheim Investigational Site | Fremont | California | — | — |
| 1160.173.032 Boehringer Ingelheim Investigational Site | Moreno Valley | California | — | — |
| 1160.173.034 Boehringer Ingelheim Investigational Site | Oceanside | California | — | — |
| 1160.173.025 Boehringer Ingelheim Investigational Site | Salinas | California | — | — |
| 1160.173.033 Boehringer Ingelheim Investigational Site | San Pedro | California | — | — |
| 1160.173.024 Boehringer Ingelheim Investigational Site | Wilmington | Delaware | — | — |
| 1160.173.010 Boehringer Ingelheim Investigational Site | Washington D.C. | District of Columbia | — | — |
| 1160.173.020 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1160.173.036 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1160.173.012 Boehringer Ingelheim Investigational Site | Largo | Florida | — | — |
| 1160.173.013 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1160.173.005 Boehringer Ingelheim Investigational Site | Columbus | Georgia | — | — |
| 1160.173.018 Boehringer Ingelheim Investigational Site | Springfield | Missouri | — | — |
| 1160.173.019 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1160.173.026 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1160.173.027 Boehringer Ingelheim Investigational Site | Neptune City | New Jersey | — | — |
| 1160.173.014 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina | — | — |
| 1160.173.001 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | — | — |
| 1160.173.008 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1160.173.037 Boehringer Ingelheim Investigational Site | Lancaster | South Carolina | — | — |
| 1160.173.030 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | — | — |
| 1160.173.011 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | — | — |
| 1160.173.006 Boehringer Ingelheim Investigational Site | Live Oak | Texas | — | — |
| 1160.173.021 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | — | — |
| 1160.173.035 Boehringer Ingelheim Investigational Site | Waukesha | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01896297, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 30, 2016 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01896297 live on ClinicalTrials.gov.