Atrial fibrillation is the most common arrhythmia encountered in clinical practice. Atrial fibrillation is usually associated with age and general physical condition, rather than with a specific cardiac event. While not directly life-threatening, atrial arrhythmias can cause discomfort and can lead to stroke or congestive heart failure, and overall, increase morbidity.
Conditions
Interventions
Product Code: RSD1235-SR 300 mg overencapsulated tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not assigned
CAS Number: 748810-28-8
Current Sponsor code: RSD1235
Other descriptive na
Sponsors
Cardiome Pharma Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in the study subjects must: - Comprehend and sign a written informed consent form, (including at US sites, HIPAA Authorisation; and at European sites, per EU Privacy Directive as implemented by member states in national law, as applicable); - Be over 18 to 85 years of age; - Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from submission until 3 months after the last dose of study medication; - Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration; - Have adequate anticoagulant therapy in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al.,2001); - Be haemodynamically stable (100mmHg =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To participate in this study a subject may not: - Have known prolonged QT syndrome or uncorrected QT interval of >0.460 sec as measured at Screening on a 12-lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT). - Have a QRS >0.14 sec; - Documented previous episodes of second or third-degree atrioventricular block; - Have known bradycardia, sick-sinus syndrome or pacemaker; - Have significant 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 hospitalised for heart failure in the previous 6 months; - Have unstable angina; - Have a myocardial infection (MI) or acute coronary syndrome within 30 days prior to entry into the study; - Have serious pulmonary, hepatic, metabolic, renal (serum creatinine > 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety; - Have known secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation 5.5 mmol/L (>5.5 mEq/L) or Magnesium (Mg²+) below the lower limit of normal (<1.3 mEq/L). (Both K+ and Mg²+ should be corrected prior to dosing); - Have clinical evidence of digoxin toxicity; - Have received an oral Class I or Class III antiarrhythmic agent (including solalol) within 3 days of randomization 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: The objectives of this study are to determine the safety and tolerability of two dose levels of RSD1235-SR and obtain preliminary information on the efficacy of RSD1235-SR in preventing the recurrence of atrial fibrillation or atrial flutter in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration.;Primary end point(s): SAFETY ASSESSMENTS Safety assessments will consist of monitoring and recording of all adverse events (AE) and serious adverse events (SAE), the regular measurement of vital signs and 12-lead ECGs. Safety laboratory assays and physical exams will also be performed. EFFICACY ASSESSMENTS All efficacy parameters based on ECG data will be evaluated based on ECGs from TTMs, and 12-lead ECGs. AF symptoms (with patient diary and SCL) and Quality of Life will also be assessed. PHARMACOKINETIC ASSESSMENTS Population PK approach will be used to evaluate the RSD1235-SR PK profile in this study. | — |
Countries
Czech Republic, Denmark, Sweden
Outcome results
None listed