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A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02156076
First received: May 12, 2014
Last updated: November 20, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Drug: BMS-919373
Drug: Placebo (Matching with BMS-919373)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percent change from baseline in Atrial Fibrillation Burden (percent of time in which a subject is in Atrial Fibrillation) [ Time Frame: Day 8 to Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessments will be based on review of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests collected at specified time points and continuous monitoring of safety events of special interest [ Time Frame: From initiation of study drug until follow up visit (approximately 50 days) ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of BMS-919373 [ Time Frame: Day 1 and Day 22 ] [ Designated as safety issue: No ]
  • Trough observed concentration (Cmin) of BMS-919373 [ Time Frame: Day 8, Day 22, and Day 29 ] [ Designated as safety issue: No ]
    Estimates of individual exposure parameters will be derived from the population pharmacokinetics (PK) model

  • Oral clearance (CL/F) of BMS-919373 [ Time Frame: Day 36, Day 50 ] [ Designated as safety issue: No ]
    PK data collected will be used to develop a population PK model to estimate model-based parameters

  • Central volume of distribution (Vc/F) of BMS-919373 [ Time Frame: Day 8, Day 22, and Day 29 ] [ Designated as safety issue: No ]
    PK data collected will be used to develop a population PK model to estimate model-based parameters

  • Absorption rate constant (Ka) of BMS-919373 [ Time Frame: Day 8, Day 22, and Day 29 ] [ Designated as safety issue: No ]
    PK data collected will be used to develop a population PK model to estimate model-based parameters

  • Average concentration (Cavg) of BMS-919373 [ Time Frame: Day 8, Day 22, and Day 29 ] [ Designated as safety issue: No ]
    Estimates of individual exposure parameters will be derived from the population PK model

  • Area under the concentration-time curve (AUC) at steady state of BMS-919373 [ Time Frame: Day 8, Day 22, and Day 29 ] [ Designated as safety issue: No ]
    Estimates of individual exposure parameters will be derived from the population PK model

  • Efficacy based on time to first AF recurrence (symptomatic or asymptomatic) [ Time Frame: From initiation of study drug until follow up visit (approximately 50 days) ] [ Designated as safety issue: No ]
  • Efficacy based on number of AF episodes [ Time Frame: From initiation of study drug until follow up visit (approximately 50 days) ] [ Designated as safety issue: No ]
  • Efficacy based on average duration of AF per episode [ Time Frame: From initiation of study drug until follow up visit (approximately 50 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: BMS-919373
Other Name: IKur Inhibitor
Experimental: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
Drug: BMS-919373
Other Name: IKur Inhibitor
Experimental: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
Drug: BMS-919373
Other Name: IKur Inhibitor

Detailed Description:

Primary Purpose: Other: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the NUVANT Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Signed informed consent
  • Paroxysmal Atrial Fibrillation (pAF) with documented AF (by ECG or electrocardiographic monitoring) within 6 months prior to screening
  • Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)
  • Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured within 12 months of enrollment
  • Echocardiographically measured left atrial (LA) diameter ≤4.5 cm, measured within 12 months of enrollment

Exclusion Criteria:

  • Women of childbearing potential
  • AFB < 3% or > 70%, during both screening periods independently
  • Permanent or persistent Atrial Fibrillation
  • Cardioversion within 3 months of study drug administration
  • Any history of TIA or stroke
  • Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with minimal exertion)
  • Heart failure of NYHA class II (symptoms of heart failure with routine levels of exertion)with ejection fraction <40% as measured by echocardiography at any time within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥ 40% over this period will not counter this exclusion)
  • Valvular heart disease (including any valvular insufficiency or stenosis greater than"mild")
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02156076

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 35 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02156076     History of Changes
Other Study ID Numbers: CV205-005
Study First Received: May 12, 2014
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014