A PHASE III PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, TOLERANCE AND EFFICACY STUDY OF RSD1235 IN SUBJECTS WITH ATRIAL FIBRILLATION OR ATRIAL FLUTTER - ACT III

Phase 1

• Conditions: Arrhythmias are abnormal rhythms of the heart. The term arrhythmia refers to a deviation from the normal sequence of initiation and conduction of electrical impulses, which cause the heart to beat. Arrhythmias may occur in the atria or the ventricles. Atrial arrhythmias are widespread and relatively benign.; MedDRA version: 6.1Level: PTClassification code 10003658

• Registration Number: EUCTR2004-000984-81-DK
• Lead Sponsor: Cardiome Pharma Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

a)Comprehend and sign a written informed consent and at US sites, HIPAA Authorization; and at Canadian sites, PIPEDA Authorization;
b)Be 18 years of age or older;
c)Women must be non-pregnant, non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30-day follow-up. Methods of birth control considered to be effective would include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilization;
d)Have either AF or AFL (with or without symptoms) that has been sustained for greater than 3 hours and up to 45 days. The presence of atrial arrhythmia will be documented by a 12-lead ECG recording at Screening. For this protocol AFL will be limited to typical” AFL based on the following criteria: AFL with a regular atrial rate of 220-320 bpm with a typical sawtooth pattern in leads II, III and aVF and predominantly negative flutter waves in V6 and positive or biphasic in V1. Atrial fibrillation is characterized by atrial activity which is either absent or chaotic both in amplitude and in rate. Non-typical forms of AFL will be categorized as AF;
e)Have adequate anticoagulant therapy in the judgment of the Investigator. (If AF/AFL has lasted more than 48 hours then subjects should be managed in accordance with standard of practice as recommended by ACC/AHA/ESC practice guidelines) (1);
f)Systolic blood pressure (BP) above 90 mmHg and less than 160 mmHg and diastolic BP less than 95 mmHg at screening and baseline. Blood pressures will be measured 3 times within 5 minutes, after resting supine for 5 minutes and averaged to determine a baseline BP.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Have known or suspected prolonged QT or uncorrected QT interval of >0.440sec as measured at Screening on a 12 lead ECG, familial long QT syndrome, or previous Torsades de Pointes;
b)Have symptomatic bradycardia or ventricular rate less than 50 bpm as documented by 12-lead ECG at Screening, unless controlled by a pacemaker;
c)Have a QRS interval > 0.14 sec unless subject has pacemaker at screening;
d)Have Class IV congestive heart failure (HF) or HF requiring intravenous inotrope therapy, or be in cardiogenic or septic shock or other forms of shock requiring vasopressors or mechanical ventilation;
e)Have a Myocardial Infarction (MI), acute coronary syndrome or cardiac surgery within 30 days prior to randomization;
f)Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235;
g)Have any known secondary causes of AF/AFL such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia (oxygen saturation less than 90% on room air);
h)Have serious pulmonary, hepatic, metabolic, renal, gastrointestinal, central nervous system or psychiatric disease, infection, febrile illness (oral temperature > 38.5°C), end stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
i)Have failed electrical cardioversion for AF or AFL at any time;
j)Have uncorrected electrolyte imbalance (serum potassium of less than 3.5 mmol/L must be corrected and documented 6 hours or less prior to randomization);
k)Have clinical evidence of digoxin toxicity in the opinion of the Investigator;
l)Have received intravenous Class I or Class III antiarrhythmic drugs or IV amiodarone within 24 hours prior to randomization;
m)Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
n)Have any other surgical or medical condition that, in the judgment of the Investigator might warrant exclusion or be contraindicated for safety reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified