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NCT01522651 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

A Phase 2 study of Atrial Fibrillation, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
134
Enrollment target
20
Study locations

NCT01522651 is a Phase 2 study of Atrial Fibrillation that has completed, run by Gilead Sciences. The registered enrollment target is 134 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01522651, a Phase 2 study of Atrial Fibrillation, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
134 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.

Conditions Studied

Atrial Fibrillation

Interventions

  • DRUG Ranolazine
  • DRUG Dronedarone
  • DRUG Ranolazine placebo
  • DRUG Dronedarone placebo

Study Locations (20)

California

  • Investigational Site - Beverly Hills
  • Investigational Site - Newport Beach
  • Investigational Site - San Francisco

Maryland

  • Investigational Site - Takoma Park
  • Investigational Site - Towson

Bavaria

  • Investigational Site - München
  • Investigational Site - Würzburg

Other

  • Investigational Site - Coburg
  • Investigational Site - Frankfurt

Colorado

  • Investigational Site - Aurora

District of Columbia

  • Investigational Site - Washington D.C.

Florida

  • Investigational Site - Lakeland

New York

  • Investigational Site - Utica

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2012-01-24
Est. Completion 2014-03-10
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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What the Registry Record Tells You About NCT01522651

The ClinicalTrials.gov registry entry for NCT01522651 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (96% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 4 interventions - of which Ranolazine is the first listed.

NCT01522651 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Maryland, Bavaria.

Frequently Asked Questions

What is clinical trial NCT01522651 about?

NCT01522651 is a clinical study titled "Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation". The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia...

What is the current status of trial NCT01522651?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2012-01-24. Estimated completion is 2014-03-10.

What conditions does trial NCT01522651 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT01522651?

The interventions under investigation include: Ranolazine (DRUG), Dronedarone (DRUG), Ranolazine placebo (DRUG), Dronedarone placebo (DRUG).

Who is sponsoring clinical trial NCT01522651?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01522651 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Maryland. 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.