The trial is to investigate the efficacy of the new drug ATI-2042 to reduce the atrial tachyarrhythmia burden in patients with paroxysmal atrial fabrilation. ATI-2042 is designed to act like Amiodarone but with fewer side effects. MedDRA version: 9.1 Level: LLT Classification code 10003661 Term: Atrial fibrillation paroxysmal
Conditions
Interventions
Product Code: ATI-2042
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ATI-2042
Other descriptive name: {(2S) butan-2-yl 2-[3-(4-{2-(diethylamino) ethoxy}-3,5-diiodobenzoyl) benzofuran-2-yl-
Sponsors
ARYx Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 and above. 2. Proven paroxysmal atrial fibrillation (ECG, Holter monitor, or pacemaker diagnosis obtained by the clinical site or patient’s prior medical record documenting clear evidence of a diagnosis of PAF). 3. Pacemaker with appropriate AF diagnostic and recording capabilities implanted for at least 6 weeks. Additional pacemaker requirements include: a. Dual chamber with bipolar leads. b. Able to diagnose and log atrial tachyarrhythmia events. c. Able to have atrial tachyarrhythmia treatment algorithms turned off. d. Capable of storing at least 4 weeks AT/AF data between downloads. e. Able to record and store electrograms. 4. Atrial P waves of adequate amplitude to allow accurate sensing and assessment of AT/AF episodes and no obvious indication of frequent oversensing or undersensing. 5. Able to have pacemaker atrial antitachyarrhythmia treatment algorithms turned off for the duration of the study. 6. Able to understand study requirements and willing to follow instructions, attend all required study visits, and undergo all planned tests. 7. Able and willing to sign an Institutional Review Board/Research Ethics Board (IRB/REB)-approved informed consent form to participate in this study. 8. Women: Unable to bear children, that is, post-menopausal (absence of vaginal bleeding or spotting) for at least one year or surgically sterile. 9. Men: Starting at the time of study drug administration until completion of the 12-week treatment period, must be willing to use an approved method of contraception (which may include use of a condom with spermicide or use by partner of oral, implantable, or injectable contraceptives, IUD, diaphragm with spermicide) or will have a sterile sex partner. 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: 1. Known allergy or hypersensitivity to amiodarone or iodine. 2. Chronic treatment with amiodarone within 3 months prior to screening. 3. Termination of previous amiodarone treatment for severe toxicity. 4. Cardioversion within 1 month of screening. 5. Treatment with catheter ablation within 3 months prior to screening. 6. Known severe left ventricular dysfunction (EF less than 25%). 7. CHF with NYHA Class III or IV. 8. Unstable angina, myocardial infarction, PTCA, or CABG within 3 months of screening. 9. Prior history of sustained ventricular tachycardia or Torsades de Pointes. 10. reatment with rhythm control medication (Singh-Vaughan Williams Class I or Class III) within five half-lives time of entry into baseline period (rate control drugs are alloeable). 11. Currently taking clinically necessary anti-arrhythmic treatment taht cannot be stopped for participation in this study. 12. Any clinically significant comorbidity or out-of-range laboratory values at screening that in the opinion of the Investigator or Medical Monitor would put the patient at unacceptable risk or interfere with the conduct of the study (such as end-stage renal disease, severe pulmonary disease or terminal cancer). 13. Treatment with any other investigational drug or device within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To study the efficacy of ATI-2042 in reducing atrial tachyarrhythmia (AT/AF) burden in patients with PAF, compared to placebo, for 12 weeks of treatment. - To study the safety and tolerability of ATI-2042 for up to 12 weeks of treatment.;Secondary Objective: - To study the effect of ATI-2042 versus placebo on the number and duration of AT/AF episodes. - To study the effect of ATI-2042 versus placebo on symptoms associated with PAF using a structured questionnaire.;Primary end point(s): Efficacy: - AT/AF burden (total time spent in AT/AF as a percentage of total observation time) over the 12-week treatment period. Safety: - Adverse event type and incidence. - Change from baseline in ECGs, clinical laboratory assessments, vital signs, physical examinations, chest X-rays. - Eye examinations and pulmonary function tests. | — |
Countries
Germany
Outcome results
None listed