A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02156076|
Recruitment Status : Terminated (Sponsor decision based on business reasons, unrelated to safety)
First Posted : June 5, 2014
Results First Posted : May 22, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Drug: BMS-919373 Drug: Placebo (Matching with BMS-919373)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation|
|Actual Study Start Date :||July 25, 2014|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||June 1, 2016|
Placebo Comparator: Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
Drug: Placebo (Matching with BMS-919373)
Experimental: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
Experimental: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
Experimental: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
- Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System [ Time Frame: Day 8 to Day 29 ]AFB is defined as the percent of time spent in atrial fibrillation (AF). AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system. This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days. The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB.
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death [ Time Frame: Up to Day 50 ]An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.
- Maximum Observed Concentarion (Cmax) of BMS-919373 [ Time Frame: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose ]Cmax is defined as the maximum observed concentration of BMS-919373.
- Trough Observed Concentration (Cmin) of BMS-919373 [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]Ctrough is defined as the minimum estimated plasma concentration at steady state.
- Oral Clearance (CL/F) of BMS-919373 [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
- Central Volume of Distribution (Vc/F) of BMS-919373 [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Vc/F is a hypothetical volume into which a drug initially distributes upon administration.
- Absorption Rate Constant (Ka) of BMS-919373 [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]Ka is the absorption rate constant.
- Average Concentration (Cavg) of BMS-919373 at Steady State [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]Cavg is defines as the average concentration at steady state.
- Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373 [ Time Frame: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28) ]AUC is defined as the area under the concentration-time curve at steady state.
- Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic) [ Time Frame: Day 8 to Day 29 ]The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both "System-triggered" and "Patient-triggered" results and report them separately. "System-triggered" results will include both symptomatic and asymptomatic findings, while "Patient-triggered" results will be the symptomatic ones triggered to report by patients. The analysis will be done both for "System-triggered" and for "Patient-triggered" results.
- Total Number of Atrial Fibrillation Episodes [ Time Frame: Day 8 to Day 29 ]The total number AF episodes were derived from AF episode histogram data over the monitoring period.
- Average Duration of Atrial Fibrillation Per Episode [ Time Frame: Day 8 to Day 29 ]The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156076
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|