Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01356914
First received: April 15, 2011
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.


Condition Intervention Phase
Atrial Fibrillation
Drug: BMS-914392
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients With Paroxysmal Atrial Fibrillation and Permanent Pacemaker

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Atrial Fibrillation Burden [ Time Frame: At screening (baseline) ] [ Designated as safety issue: No ]
  • Atrial Fibrillation Burden [ Time Frame: Prior to randomization to study drug ] [ Designated as safety issue: No ]
  • Atrial Fibrillation Burden [ Time Frame: On Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Atrial Fibrillation Burden [ Time Frame: On Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Atrial Fibrillation Burden [ Time Frame: On Day 22 of each cross-over period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events and type of adverse events [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Number of participants with adverse events and type of adverse events [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Number of participants with adverse events and type of adverse events [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • Number of Atrial fibrillation (AF) episodes [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Number of AF episodes [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Number of AF episodes [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • Duration of AF episodes [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Duration of AF episodes [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Duration of AF episodes [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • Heart Rate [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Heart Rate [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Heart Rate [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • Severity of AF (SAF) scale score at the end of each study period [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Severity of AF (SAF) scale score at the end of each study period [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Severity of AF (SAF) scale score at the end of each study period [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) [ Time Frame: At Day 1 of each cross-over period ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) [ Time Frame: At Day 8 of each cross-over period ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) [ Time Frame: At Day 22 of each cross-over period ] [ Designated as safety issue: No ]
  • BMS-914392 plasma concentrations and exposures during each study period [ Time Frame: At Days 1, 8 and 22 of each cross-over period ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A: BMS-914392 Drug: BMS-914392
Tablets, Oral, 10 mg, Every Day (QD), 20 days
Other Name: BMS-914392
Experimental: Treatment B: BMS-914392 Drug: BMS-914392
Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days
Other Name: BMS-914392
Experimental: Treatment C: BMS-914392 Drug: BMS-914392
Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days
Other Name: BMS-914392
Placebo Comparator: Treatment D: Placebo Drug: Placebo
Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paroxysmal atrial fibrillation (AF)
  • Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
  • 1-50% AF burden on pacemaker interrogation at screening.
  • Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.

Exclusion Criteria:

  • Persistent or permanent AF.
  • AF Burden <1% or > 50%.
  • Current or history of neurological diseases and mental disorders.
  • Ejection Fraction < 45%.
  • Severe mitral or aortic valve dysfunction.
  • TIA (Transient Ischemic Attack) within last 12 months.
  • Acute coronary syndrome in the last 2 months.
  • Previous AF ablation.
  • Cardioversion in last 3 months.
  • Current kidney or liver disease, or current cancer.
  • History of neurological and mental disorders.
  • Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
  • Screening lab test results outside of allowed limits per protocol.
  • QTcF > 450 msec.
  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: NCT01356914

Locations
United Kingdom
Eastbourne General Hospital
Eastbourne, United Kingdom, BN21 2UD
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: NCT01356914     History of Changes
Other Study ID Numbers: CV203-010, 2010-022947-39
Study First Received: April 15, 2011
Last Updated: August 29, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 20, 2014