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

A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125320

Enrollment

190

Registered

2005-08-01

Start date

2004-06-30

Completion date

2007-02-28

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Keywords

Treatment

Brief 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.

Detailed description

This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

Interventions

DRUGRSD1235

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery

Exclusion criteria

* Unstable Class IV heart failure

Design outcomes

Primary

Measure	Time frame
Effectiveness of RSD1235	90 minutes post infusion

Secondary

Measure	Time frame
Proportion of patients in sinus rhythm at 90 minutes	Time from first exposure to conversion to sinus rhythm

Countries

Argentina, Canada, Denmark, India, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026