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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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
Astellas Pharma

165 total trials

What the finished NCT00115791 record still lists

NCT00115791 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower).

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 names 20 study sites across 15 states, led by 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.

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 NCT00115791's enrollment target sits among peer trials

276 84th of 202 higher than 118 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00115791, the US trial registry maintained by the National Library of Medicine. NCT00115791 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.