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NCT00476112 · ClinicalTrials.gov registry record · Phase 2

A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter

A Phase 2 study of Atrial Flutter, sponsored by Advanz Pharma.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
20
Study locations

NCT00476112 is a Phase 2 study of Atrial Flutter that has completed, run by Advanz Pharma. The registered enrollment target is 60 participants, below the 2,121-participant average among 23 other Atrial Flutter trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00476112, a Phase 2 study of Atrial Flutter, has completed, sponsored by Advanz Pharma.

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

Study Summary

This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.

Conditions Studied

Interventions

  • DRUG Vernakalant Injection 20 mg/mL

Study Locations (20)

Other

  • Aalborg University - Aalborg
  • H:S Bispebjerg Hospital - Copenhagen
  • Centralsygehuset Esbjerg Varde - Esbjerg
  • Glostrup Amtssygehus - Glostrup Municipality
  • Gentofte Amtssygehus - Hellerup
  • Herlev Amtssygehus, Kardiologisk - Herlev
  • Sygehus Vendsyssel Hjorring - Hjørring

Alberta

  • Heart Health Institute, Rockyview General Hospital - Calgary
  • University of Calgary - Calgary
  • University of Alberta Hospital - Edmonton

Quebec

  • Institut de Cardiologie de Montreal - Montreal
  • Hopital Notre-Dame du CHUM - Montreal
  • CHUM-Hotel-Dieu de Montreal - Montreal

Virginia

  • Medical College of Virginia - Richmond
  • McGuire VA Medical Center - Richmond

Ontario

  • Hamilton Health Sciences, Hamilton General Hospital - Hamilton
  • Ottawa Hospitals (Civic & General) - Ottawa

California

  • Regional Cardiology Associates - Sacramento

Michigan

  • Thoracic and Cardiovascular Institute - Lansing

Wisconsin

  • Marshfield Clinic - Marshfield

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2003-08
Est. Completion 2004-09
Phase Phase 2

Sponsor

Advanz Pharma

4 total trials

What the Registry Record Tells You About NCT00476112

The ClinicalTrials.gov registry entry for NCT00476112 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,121-participant average among 23 other Atrial Flutter trials with a reported enrollment target (97% lower). The listed sponsor is Advanz Pharma, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Flutter appearing as the primary indexed condition, and to 1 intervention - of which Vernakalant Injection 20 mg/mL is the first listed.

NCT00476112 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Alberta, Quebec.

Frequently Asked Questions

What is clinical trial NCT00476112 about?

NCT00476112 is a clinical study titled "A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter". This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.

What is the current status of trial NCT00476112?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2003-08. Estimated completion is 2004-09.

What conditions does trial NCT00476112 study?

This clinical trial studies the following conditions: Atrial Flutter.

What interventions are being tested in trial NCT00476112?

The interventions under investigation include: Vernakalant Injection 20 mg/mL (DRUG).

Who is sponsoring clinical trial NCT00476112?

This trial is sponsored by Advanz Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00476112 being conducted?

This trial has 20 study locations across California, Michigan, Virginia, Wisconsin, Alberta. 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.