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

Astellas

Status and phase: Completed; Phase 3

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Drug: RSD1235

Study type: Interventional

Funder types: Industry

Identifiers

NCT00125320

1235-0104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Unstable Class IV heart failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind