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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 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.

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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.

Conditions Studied

Atrial Fibrillation

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

FieldValue
Enrollment Target 63 participants
Start Date 2013-07
Est. Completion 2015-10
Phase Phase 4

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01896297

The ClinicalTrials.gov registry entry for NCT01896297 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.