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

NCT00476112 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-04-02

No results posted yet for this study

Summary

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

Conditions

  • Atrial Flutter

Interventions

DRUG

Vernakalant Injection 20 mg/mL

Sponsors & Collaborators

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY

  • Advanz Pharma

    lead INDUSTRY

Principal Investigators

  • Sheila Grant, MBA · Advanz Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • United States
  • Canada
  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476112 on ClinicalTrials.gov