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NCT00115791 · ClinicalTrials.gov registry record · Phase 3

Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

A Phase 3 study of Atrial Fibrillation and Atrial Flutter, sponsored by Astellas Pharma.

Completed
Registry status
Phase 3
Development phase
276
Enrollment target
20
Study locations

NCT00115791 is a Phase 3 study of Atrial Fibrillation and Atrial Flutter that has completed, run by Astellas Pharma. The registered enrollment target is 276 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00115791, a Phase 3 study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 3
Development phase
276 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

Conditions Studied

Atrial Fibrillation Atrial Flutter

Interventions

  • DRUG placebo
  • DRUG RSD1235

Study Locations (20)

Florida

  • Investigative Site - Gainesville
  • Investigative Site - Orlando
  • Investigative Site - Port Charlotte

Alabama

  • Investigative Site - Birmingham
  • Investigative Site - Huntsville

Michigan

  • Investigative Site - Lansing
  • Investigative Site - Petoskey

Texas

  • Investigative Site - Amarillo
  • Investigative Site - Houston

Indiana

  • Investigative Site - Indianapolis

Louisiana

  • Investigative Site - Shreveport

Maryland

  • Investigative Site - Baltimore

Minnesota

  • Investigative Site - Saint Paul

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2004-06
Est. Completion 2005-06
Phase Phase 3

Sponsor

Astellas Pharma

165 total trials

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What the Registry Record Tells You About NCT00115791

The ClinicalTrials.gov registry entry for NCT00115791 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 276 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 (91% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00115791 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Alabama, Michigan.

Frequently Asked Questions

What is clinical trial NCT00115791 about?

NCT00115791 is a clinical study titled "Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter". The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

What is the current status of trial NCT00115791?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2004-06. Estimated completion is 2005-06.

What conditions does trial NCT00115791 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.

What interventions are being tested in trial NCT00115791?

The interventions under investigation include: placebo (DRUG), RSD1235 (DRUG).

Who is sponsoring clinical trial NCT00115791?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00115791 being conducted?

This trial has 20 study locations across Alabama, Florida, Indiana, Louisiana, 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.