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

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

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276 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RSD1235

2

Placebo Comparator group

Treatment:

Drug: placebo