Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00281554

Acronym

ACT 4

Enrollment

254

Registered

2006-01-25

Start date

2005-10-31

Completion date

2007-01-31

Last updated

2008-04-03

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

Conditions

Atrial Fibrillation

Keywords

Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235

Brief summary

This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Interventions

DRUGRSD1235

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject must have symptomatic AF * Subject must have adequate anticoagulant therapy

Exclusion criteria

* Subject may not have Class IV congestive heart failure. * Subject may not have uncorrected electrolyte imbalance.

Design outcomes

Primary

Measure	Time frame
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute	Infusion plus 1.5 hours

Secondary

Measure	Time frame
Evaluate safety	End of study

Countries

Argentina, Canada, Denmark, South Africa, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026