A Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centered Safety, Tolerability and Efficacy Study of RSD1235-SR to Prevent Atrial Fibrillation (AF) Recurrence in Subjects Post-Conversio

Phase 2

Completed

• Conditions: arrythmia; palpitations; 10007521

• Registration Number: NL-OMON30473
• Lead Sponsor: Cardiome Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

-Signed and dated written informed consent form;
-Be 18 to 85 years of age;
-Men and women must be using an effective method of birth control;
-Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
-Have adequate anticoagulant therapy;
-Be heamodynamically stable;
-Have a body weight between 45 and 113 kg.

Exclusion Criteria

-Pregnant or breast-feeding women;
-Have known prolonged QT syndrome or QTcB-interval of >0,500 sec, familial long QT
syndrome, previous Torsades de Pointes, ventricular fibrillation or sustained ventriculard ventrikeltachycardia;
-Have a QRS >0,140 sec;
-Documented previous episodes of second or third-degree atrioventricular block;
-Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
-Have clinically significant aortic valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
-Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
-Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
-Have serious diseases that could interfere with the conduct or validity of the study or compromise subject safety;
-Have known concurrent temporary secondary causes of AF;
-Have specific (stated in the protocol) values of K+ en Mg2+;
-Have clinical evidence of digoxin toxicity;
-Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
-Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
-Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
-Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Time to first documented recurrence of symptomatic sustained AF;<br /><br>2) Time to first documented recurrence of symptomatic or asymptomatic<br /><br>sustained AF;<br /><br>3) Time to first documented recurrence of symptomatic AF;<br /><br>4) Time to first documented recurrence of symptomatic or asymptomatic AF;<br /><br>5) Proportion of subjects in sinus rhythm on Day 90;<br /><br>6) Improvement in AF symptoms as assessed by an AF symptom checklist;<br /><br>7) Improvement in QOL as measured by SF-36.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>