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NCT01896297 · ClinicalTrials.gov registry record · Phase 4
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
A Phase 4 study of Atrial Fibrillation, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT01896297: Completed Phase 4 study of Atrial Fibrillation, sponsored by Boehringer Ingelheim.
NCT01896297 is a Phase 4 study of Atrial Fibrillation that has completed, run by Boehringer Ingelheim. The registered enrollment target is 63 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896297, a Phase 4 study of Atrial Fibrillation, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Pradaxa, dabigatran etexilate
Study Locations (20)
California
- 1160.173.023 Boehringer Ingelheim Investigational Site - Fremont
- 1160.173.032 Boehringer Ingelheim Investigational Site - Moreno Valley
- 1160.173.034 Boehringer Ingelheim Investigational Site - Oceanside
- 1160.173.025 Boehringer Ingelheim Investigational Site - Salinas
- 1160.173.033 Boehringer Ingelheim Investigational Site - San Pedro
Florida
- 1160.173.020 Boehringer Ingelheim Investigational Site - Jacksonville
- 1160.173.036 Boehringer Ingelheim Investigational Site - Jacksonville
- 1160.173.012 Boehringer Ingelheim Investigational Site - Largo
- 1160.173.013 Boehringer Ingelheim Investigational Site - Tampa
Missouri
- 1160.173.018 Boehringer Ingelheim Investigational Site - Springfield
- 1160.173.019 Boehringer Ingelheim Investigational Site - St Louis
- 1160.173.026 Boehringer Ingelheim Investigational Site - St Louis
Pennsylvania
- 1160.173.001 Boehringer Ingelheim Investigational Site - Altoona
- 1160.173.008 Boehringer Ingelheim Investigational Site - Pittsburgh
Arkansas
- 1160.173.002 Boehringer Ingelheim Investigational Site - Hot Springs
Delaware
- 1160.173.024 Boehringer Ingelheim Investigational Site - Wilmington
District of Columbia
- 1160.173.010 Boehringer Ingelheim Investigational Site - Washington D.C.
Georgia
- 1160.173.005 Boehringer Ingelheim Investigational Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
What the finished NCT01896297 record still lists
NCT01896297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Pradaxa, dabigatran etexilate is the first listed.
NCT01896297 names 20 study sites across 10 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT01896297 about?
NCT01896297 is a clinical study titled "Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function". 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 sev...
What is the current status of trial NCT01896297?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2013-07. Estimated completion is 2015-10.
What conditions does trial NCT01896297 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT01896297?
The interventions under investigation include: Pradaxa, dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT01896297?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01896297 being conducted?
This trial has 20 study locations across Arkansas, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01896297's enrollment target sits among peer trials
63 163rd of 202 higher than 39 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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