Atrial Fibrillation MedDRA version: 14.1 Level: LLT Classification code 10003661 Term: Atrial fibrillation paroxysmal System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: BMS-914392-01 / NTC-801F
Product Code: BMS-914392-01 / NTC-801F
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BMS-914392-01
Other descriptive name: NTC-801F
Concentration
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy • Paroxysmal atrial fibrillation (AF) within 6 month prior to screening. • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics that was implanted for a primary or secondary indication at least 1 month with a stable peacemaker assessment prior to screening. a. 1-50% AF burden (% of time spend in AF) on pacemaker interrogation at screening. • Any oral anticoagulant approved for use in atrial fibrillation for prevention of stroke or other embolic disease. • Able to tolerate withdrawal of antiarrhythmic therapy. • Able to tolerate pacemaker antiarrhythmic algorithms turned off. • Clinically stable at the time of randomization as determined by the investigator. 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 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: • AF burden 50% on pacemaker interrogation prior to first dosing. • Permanent AF. • Development of persistent AF prior to first dosing. • Any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening. • Current or history of neurological diseases and mental disorders, including syncope, convulsive disorders such as epilepsy, central thrombosis and cerebral embolism, stroke, or accidents involving brain injuries. • History of TIA in the last 12 months. • History of Ventricular Arrythmia. • Cardioversion within 3 months of study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess, by the use of long term beat to beat pacemaker monitoring, the effect of BMS-914392 on the reduction of placebo-corrected AF burden (% of time spent in AF) in pacemaker subjects with paroysmal AF.;Secondary Objective: • To assess the effect of BMS-914392 on the total number of AF episodes, average duration of AF per episode, and average sinus rhythm duration derived from continuous pacemaker monitoring. • To assess the effect of BMS-914392 on subject-perceived AF-related symptoms through self-reporting using the Canadian Cardiovascular Society Atrial Fibrillation Severity Scale (CCS-AFSS). • To assess the safety and tolerability of BMS-914392. • To assess the effect of BMS-914392 on PR, QRS, RR, QT, and QTc intervals derived from 12-lead ECGs for periods of sinus rhythm. • To assess the pharmacokinetics of BMS-914392 on Day 1 and Day 8 of Period 1, 2, 3, and 4.;Primary end point(s): • AF burden: percent of time in which a subject is in AF ;Timepoint(s) of evaluation of this end point: Measured from Day 8 to Day 22 of Periods 1, 2, 3, 4 and Day 1 to Day 8 of period 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Total number of AF episodes • Average duration of AF per episode • Average sinus rhythm duration • Self-reported AF symptoms • ECG intervals derived from 12-lead ECGs • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, 12-lead ECGs, physical and neurological examinations and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance. • Pharmacokinetic Measures: Observed Cmin at steady state (Day 7);Timepoint(s) of evaluation of this end point: Throughout of the Treatment Period | — |
Countries
United Kingdom
Contacts
Public ContactEU Study Start Up Unit
Bristol Myers Squibb International Corporation
Outcome results
None listed