Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

NCT00125320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2007-12-24

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

Conditions

Interventions

DRUG

RSD1235

Sponsors & Collaborators

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY
  • Advanz Pharma

    collaborator INDUSTRY
  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma US, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States
  • Argentina
  • Canada
  • Denmark
  • India
  • Poland

Study Locations

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Entities

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 NCT00125320 on ClinicalTrials.gov