Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence

Advanz Pharma221 enrolled

Overview

This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

221

Conditions

Atrial Fibrillation

Interventions

Vernakalant (oral)DRUG

Placebo comparatorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria (partial list): * Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration * Subjects must have adequate anticoagulant therapy Exclusion Criteria (partial list): * Subjects may not have Class III or Class IV congestive heart failure * Subjects may not have uncorrected electrolyte imbalance

Locations (22)

The Heart Center, P.C.

Huntsville, Alabama, United States

Cardiovascular Consultants Medical Group, Inc.

Outcomes

Primary Outcomes

All subjects who were exposed to the investigational medication were evaluated for safety.

Time frame: Subjects were assessed for safety within Day 58 of dosing

Secondary Outcomes

Recurrence of AF/AFL or withdrawal

Time frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing

Improvement in AF symptoms

Time frame: Time to improvement in AF symptoms within Day 28 of dosing

Data from ClinicalTrials.gov

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