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

Astellas Pharma Inc276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

276

Conditions

Atrial Flutter Atrial Fibrillation

Interventions

RSD1235DRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (54)

Outcomes

Primary Outcomes

To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm

Time frame: Infusion plus 1.5 hours

Secondary Outcomes

To assess the time taken from exposure to first treatment to first conversion to sinus rhythm

Time frame: End of study

Data from ClinicalTrials.gov

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Investigative Site

Birmingham, Alabama, United States

Investigative Site

Huntsville, Alabama, United States

Investigative Site

Gainesville, Florida, United States

Investigative Site

Orlando, Florida, United States

Investigative Site

Port Charlotte, Florida, United States

Investigative Site

Indianapolis, Indiana, United States

Investigative Site

Shreveport, Louisiana, United States

Investigative Site

Baltimore, Maryland, United States

Investigative Site

Lansing, Michigan, United States

Investigative Site

Petoskey, Michigan, United States

...and 44 more locations