Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115791

Enrollment

276

Registered

2005-06-27

Start date

2004-06-30

Completion date

2005-06-30

Last updated

2008-04-01

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

Atrial Flutters, Atrial Fibrillations, RSD1235

Brief 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

DRUGRSD1235

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion criteria

* Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Design outcomes

Primary

Measure	Time frame
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm	Infusion plus 1.5 hours

Secondary

Measure	Time frame
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm	End of study

Countries

Argentina, Canada, Chile, Denmark, Mexico, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026