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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
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Paroxysmal Atrial Fibrillation
Interventions Drug: BMS-919373
Drug: Placebo (Matching with BMS-919373)
Enrollment 158
Recruitment Details  
Pre-assignment Details Total 158 participants were enrolled out of which 26 participants were randomized and treated.
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Period Title: Treatment Period
Started 7 7 6 6
Completed 7 5 4 4
Not Completed 0 2 2 2
Reason Not Completed
no longer meets study criteria             0             0             1             0
Poor/non-compliance             0             1             0             0
Lost to Follow-up             0             0             0             1
Withdrawal by Subject             0             0             1             0
Subject request to discontinue treatment             0             1             0             0
Adverse Event             0             0             0             1
Period Title: Follow-up Period
Started 7 5 4 4
Completed 6 5 4 4
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo Total
Hide Arm/Group Description Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks. Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days. Total of all reporting groups
Overall Number of Baseline Participants 7 7 6 6 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 6 participants 6 participants 26 participants
70.0  (5.83) 61.0  (8.23) 65.7  (10.05) 65.0  (10.77) 65.4  (8.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 6 participants 6 participants 26 participants
Female
1
  14.3%
3
  42.9%
1
  16.7%
2
  33.3%
7
  26.9%
Male
6
  85.7%
4
  57.1%
5
  83.3%
4
  66.7%
19
  73.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 6 participants 6 participants 26 participants
Hispanic or Latino
0
   0.0%
1
  14.3%
0
   0.0%
2
  33.3%
3
  11.5%
Not Hispanic or Latino
5
  71.4%
5
  71.4%
3
  50.0%
3
  50.0%
16
  61.5%
Unknown or Not Reported
2
  28.6%
1
  14.3%
3
  50.0%
1
  16.7%
7
  26.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 6 participants 6 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   3.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
2
   7.7%
White
7
 100.0%
7
 100.0%
4
  66.7%
5
  83.3%
23
  88.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Hide Description 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.
Time Frame Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Hide Description 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.
Time Frame Up to Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included all the participants who have received at least one dose of study treatment.
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 7 7 6 6
Measure Type: Number
Unit of Measure: Participants
AEs 4 4 3 4
SAEs 0 0 0 0
Treatment-related AEs 0 3 0 0
Death 0 0 0 0
3.Secondary Outcome
Title Maximum Observed Concentarion (Cmax) of BMS-919373
Hide Description Cmax is defined as the maximum observed concentration of BMS-919373.
Time Frame Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Trough Observed Concentration (Cmin) of BMS-919373
Hide Description Ctrough is defined as the minimum estimated plasma concentration 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Oral Clearance (CL/F) of BMS-919373
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Central Volume of Distribution (Vc/F) of BMS-919373
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Absorption Rate Constant (Ka) of BMS-919373
Hide Description Ka is the absorption rate constant.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Average Concentration (Cavg) of BMS-919373 at Steady State
Hide Description Cavg is defines as the average concentration 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
Hide Description AUC is defined as the area under the concentration-time curve 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)
Hide Description 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.
Time Frame Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Total Number of Atrial Fibrillation Episodes
Hide Description The total number AF episodes were derived from AF episode histogram data over the monitoring period.
Time Frame Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Average Duration of Atrial Fibrillation Per Episode
Hide Description 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.
Time Frame Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for any participants due to termination of the study
Arm/Group Title BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg Placebo
Hide Arm/Group Description:
Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks.
Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks.
Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Approximately 50 days
Adverse Event Reporting Description All treated participants included all the participants who have received at least one dose of study treatment.
 
Arm/Group Title Placebo BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg
Hide Arm/Group Description Participants received placebo matching with BMS-919373 0 mg tablets (4 tablets) orally QD for 28 Days. Participants received loading dose of BMS-919373 3 milligram (mg) as oral tablets (each tablet of 1 mg*3) once daily (QD) for one week followed by maintenance dose of BMS-919373 2 mg as oral tablets (each tablet of 1 mg*2) QD for 3 weeks. Participants received loading dose of BMS-919373 8 mg as oral tablets (each tablet of 1 mg*3 + 5 mg*1) QD for one week followed by maintenance dose of BMS-919373 5 mg as oral tablets (each tablet of 5 mg*1) QD for 3 weeks. Participants received loading dose of BMS-919373 20 mg as oral tablets (each tablet of 5 mg*4) QD for one week followed by maintenance dose of BMS-919373 12 mg as oral tablets (each tablet of 5 mg*2 + 1 mg*2) QD for 3 weeks.
All-Cause Mortality
Placebo BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Placebo BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo BMS-919373 3/2 mg BMS-919373 8/5 mg BMS-919373 20/12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   4/7 (57.14%)   4/7 (57.14%)   3/6 (50.00%) 
Blood and lymphatic system disorders         
Eosinophilia † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Eye disorders         
Vision Blurred † 1  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Abdominal Distension † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Diarrhoea † 1  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Nausea † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Oral Pain † 1  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%) 
General disorders         
Energy Increased † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Fatigue † 1  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Medical Device Site Dermatitis † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Oedema Peripheral † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Infections and infestations         
Skin Infection † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Staphylococcal Infection † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Urinary Tract Infection † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Decreased Appetite † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Nervous system disorders         
Dizziness † 1  0/6 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/6 (0.00%) 
Head Discomfort † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Tremor † 1  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders         
Choking Sensation † 1  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Dyspnoe † 1  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis Contact † 1  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
Rash † 1  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%) 
Skin Irritation † 1  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%) 
Swelling Face † 1  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%) 
Vascular disorders         
Thrombosis † 1  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDRA version 19.0
†
Indicates events were collected by systematic assessment
Sponsor decided to terminate development of BMS-919373 for business reasons unrelated to safety, due to which data was not analyzed for maximum outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02156076    
Other Study ID Numbers: CV205-005
First Submitted: May 12, 2014
First Posted: June 5, 2014
Results First Submitted: March 21, 2019
Results First Posted: May 22, 2019
Last Update Posted: July 31, 2019