Recent Onset Atrial Fibrillation or Flutter
Conditions
Interventions
Product Name: Tedisamil
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Tedisamil
CAS Number: 90961-53-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study only when they meet all of the following criteria: 1. Willing to sign informed consent before screening examinations are performed and before the study drug is administered 2. Female, > 18 years of age 3. Subjects with documented (60 seconds rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and 90 mmHg and diastolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: 1. Male gender 2. Any woman who is pregnant, lactating, or not using medically acceptable contraception. 3. Evidence of severe hematologic, immunologic, respiratory, urogenital, gastrointestinal, hepatic, renal, endocrinologic, metabolic, nutritional, psychiatric, dermatologic, connective tissue, musculoskeletal, malignant or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments which may limit participation in or prevent completion of the study 4. Clinical evidence of hyperthyroidism 5. Demonstrated atrial or ventricular thrombus or valvular vegetation during trans-esophageal echocardiogram 6. History of a cerebrovascular accident within six months prior to randomization 7. Congestive heart failure of NYHA functional Class IV 8. History of rheumatic heart disease 9. Acute coronary syndromes at the time of randomization 10. Known history and/or electrocardiographic evidence of ventricular pre-excitation 11. History of life-threatening ventricular arrhythmias including Torsade de Pointes 12. Previous electrocardiographic evidence of second or third degree AV block 13. Sick sinus syndrome 14. Ventricular rate 200 bpm documented by 12-lead ECG 15. Myocardial infarction within 30 days prior to randomization 16. Cardiac surgery within 3 months prior to randomization 17. Need for external and internal pacemaker 18. Stent placement or PTCA within 30 days prior to randomization 19. Congenital long QT syndrome 20. QTc interval > 470 ms prior to randomization. 21. Serum creatinine > 1.8 mg/dl (159 µmol/l) 22. Serum potassium < 4.0 mEq/L (< 4.0 mmol/l) 23. Serum magnesium < 0.8 mmol/L 24. Suspicion or evidence of digitalis intoxication 25. Concurrent treatment with antiarrhythmic drugs (except for digitalis, diltiazem, or ß-blockers), not discontinued for at least five half-lives before randomization. Sotalol is disallowed medication. 26. Treatment with amiodarone within three months prior to randomization 27. Participation in a previous tedisamil clinical study 28. Participation in a clinical trial and/or intake of an investigational drug within four weeks prior to the screening visit. 29. Any history of drug abuse, including alcohol, within one year of screening visit 30. Serious drug allergy or any history of serious abnormal drug reaction 31. Severe valvular heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of tedisamil sesquifumarate to placebo in the rapid conversion to normal sinus rhythm (for at least 60 seconds), as measured by the percentage of subjects converted at any time within 2.5 hours after the start of infusion ;Secondary Objective: To determine the percentage of subjects: ? converting to normal sinus rhythm (NSR) within 2.5 hours after start of the intravenous infusion and in NSR at 2.5 hours after initiation of the infusion of tedisamil vs placebo ? converting to NSR within 2.5 hours after start of the intravenous infusion and in NSR at 24 hours after initiation of the infusion of tedisamil vs placebo ? converting to NSR within 2.5 hours after start of the intravenous infusion and in NSR at hospital discharge after initiation of the infusion of tedisamil sesquifumarate vs placebo To determine: ? the time to conversion to NSR after the start of the infusion of tedisamil vs placebo ? the energy required for DC cardioversion of tedisamil vs placebo Piggy-back pharmacoeconomic evaluation of tedisamil on pooled subject population from designated tedisamil studies The safety objective of this study is to determine the safety and tolerability of tedisamil vs placebo;Primary end point(s): the percentage of subjects converted to normal sinus rhythm (NSR) at any time within 2.5 hours of the infusion start. | — |
Countries
Hungary, Italy, Spain
Outcome results
None listed