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

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Astellas

Status and phase

Completed
Phase 3

Conditions

Atrial Fibrillation
Atrial Flutter

Treatments

Drug: placebo
Drug: RSD1235

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115791
Cardiome 1235-0504
04-7-010

Details and patient eligibility

About

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.

Enrollment

276 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

276 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: RSD1235
2
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

54

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Data sourced from clinicaltrials.gov

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