Paroxysmal Atrial Fibrillation MedDRA version: 7.0 Level: LLT Classification code 10050106
Conditions
Interventions
Product Name: ATI-2042
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: {(2S) butan-2-yl 2-[3-(4-{2-(diethylamino) ethoxy}-3,5-diiodobenzoyl) benzofuran-2-yl-]acetate}, (L) hydrogen
Sponsors
ARYx Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and Women volunteers of any ethnic group are eligible to participate in this clinical investigation provided that they meet the following criteria : a. Age 18 to 80 years b. Pacemaker with appropriate diagnostic recording capabilities (e.g. Vitatron Selectron 900 and Vitatron Selectron 9000 ) implanted for atleast 1 month c. Paroxysmal Atrial Fibrillation, defined as documented self-terminating episodes of Atrial Fibrillation , with an AF burden of 1%-50% d. Able to have pacemaker antiarrhythmic algorithms turned off or have algorithms remain on and at a stable setting, for the duration of the study e. Generally healthy and free from significant co-morbid illnesses f. Able to understand study requirements and able and willing to follow instructions, attend all required study visits and undergo all planned tests g. Able and willing to sign an Institutional Review Board / Independent Ethics Committee (IRB/EC) – approved informed consent form to participate in this study h. Unable to bear children, that is, post-menopausal (absence of vaginal bleeding or spotting) for atleast 1 year or surgically sterile 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
Exclusion criteria: The presence of any of the following will exclude subjects from participation in this study : a. Any out-of-range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the investigator b. Significant risk for Torsades de Pointe including risk factors such as an ejection fraction 75 years, significant structural heart disease demonstrated by echocardiogram within 12 months prior to screening, congestive heart failure (i.e. requiring diuretic therapy), abnormal renal function (creatinine = 2.2 mg/dL) or abnormal QTc interval (i.e. > 470 msec) c. Twelve-lead ECG documenting ventricular arrhythmias requiring pharmacotherapy d. Any other condition or clinically significant abnormal findings on the physical examination, medical history or clinical laboratory results at screening that, in the opinion of the investigator, would make the subject unsuitable for the study or put her at additional risk e. Known allergy, hypersensitivity or sensitivity to amiodarone or iodine f. Chronic treatment with amiodarone within 3 months prior to study entry g. Demonstrated lack of efficacy with prior amiodarone treatment h. Requirement for chronic warfarin therapy i. Pregnant or lactating j. Treatment with any other investigational drug within 30 days prior to study entry k. Treatment with any antiarrhythmic medication (exclusive of a stable dose of digoxin or a beta blocker or calcium blocker) within 5 half-lives prior to study entry l. Major surgery within 3 months prior to study entry or any surgery within 2 weeks prior to study entry, unless approved by the investigator and the Sponsor’s Medical Monitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine preliminarily the efficacy of ATI-2042 in treating Atrial Fibrillation in subjects with PAF who have permanent pacemakers already implanted;Secondary Objective: To assess the safety and tolerability of different doses of ATI-2042 in this subject population.;Primary end point(s): AF burden during the active treatment periods compared with the baseline period | — |
Countries
United Kingdom
Outcome results
None listed