E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paroxysmal Atrial Fibrillation |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050106 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine preliminarily the efficacy of ATI-2042 in treating Atrial Fibrillation in subjects with PAF who have permanent pacemakers already implanted |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of different doses of ATI-2042 in this subject population. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
|
|
E.4 | Principal 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 < 45%, age >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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
AF burden during the active treatment periods compared with the baseline period
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of study is declared as when the last patient completes the last visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |