Atrial FibrillationPhase 1NCT02153437
Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
A Phase 1 study testing BMS-919373 and Sotalol in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 6 sites in 2 countries.
Trial summary
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- BMS-919373 and Sotalol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Oct 2014to 20 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years to 85 years.
- Eligible patients will have a dual-chamber permanent pacemaker.
- Women who are not of childbearing potential.
Who cannot join
- Patients with a history of Atrial Fibrillation (AF) that is either:.
- Permanent (i.e. patients are only in AF and never in sinus rhythm) or.
- Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded.
- History of Transient Ischemic Attack (TIA) or stroke in the last 12 months.
- History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention.
- Complete heart block.
Show all 9Show fewer
- Planned surgery, endovascular intervention or cardioversion within the study period.
- History of atrial fibrillation.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
The University Of Calgary
Calgary, Alberta, T2N 4N1
Local Institution - 0002
Montreal, Quebec, H1T 1C8
Local Institution
Montreal, Quebec, H2W 1T8
University Of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Local Institution - 0001
Toronto, Ontario, M5B 1W8
About this study
Official title: A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
- Conditions
- Atrial Fibrillation
- Being tested
- BMS-919373, Sotalol, Placebo for BMS-919373
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-919373Drug
Also called iKUR
SotalolDrug
Also called Co Sotalol
Placebo for BMS-919373Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BMS-919373 | Experimental | BMS-919373 oral Solution/tablet single dose for one day Receives: Drug: BMS-919373 |
| Arm B: Sotalol | Active comparator | Sotalol oral Tablet single dose for one day Receives: Drug: Sotalol |
| Arm C: Placebo for BMS-919373 | Placebo comparator | Oral solution/tablet one single dose for one day Receives: Drug: Placebo for BMS-919373 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
Measured: At 0.5, 1, 2, and 4 hours following study drug administration
Secondary outcomes (5)
The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Measured: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline
Measured: At 2 hour following study drug administration
Safety assessments based on Atrioventricular interval (AVI) and change from baseline
Measured: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Wenckebach cycle length (WCL) and change from baseline
Measured: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline
Measured: At 1, 2, and 4 hours following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start30 Oct 2014
- Primary completion20 Oct 2016
- Study completion20 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153437
- Sponsor's protocol ID
- CV205-006
- Status last verified
- Dec 2023
- First submitted
- 30 May 2014
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker
- ClinicalTrials.gov ID
- NCT02153437
- Acronym / sponsor ID
- CV205-006
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 20 Oct 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BMS-919373 | Experimental | Drug: BMS-919373BMS-919373 oral Solution/tablet single dose for one day |
| Arm B: Sotalol | Active comparator | Drug: SotalolSotalol oral Tablet single dose for one day |
| Arm C: Placebo for BMS-919373 | Placebo comparator | Drug: Placebo for BMS-919373Oral solution/tablet one single dose for one day |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years to 85 years.
- Eligible patients will have a dual-chamber permanent pacemaker.
- Women who are not of childbearing potential.
Key exclusion criteria (9 listed)
- Patients with a history of Atrial Fibrillation (AF) that is either:.
- Permanent (i.e. patients are only in AF and never in sinus rhythm) or.
- Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded.
- History of Transient Ischemic Attack (TIA) or stroke in the last 12 months.
- History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-919373Also: iKUR | Drug | Arm A: BMS-919373 |
| SotalolAlso: Co Sotalol | Drug | Arm B: Sotalol |
| Placebo for BMS-919373 | Drug | Arm C: Placebo for BMS-919373 |
Primary outcome
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker
Time frame: At 0.5, 1, 2, and 4 hours following study drug administration
5 secondary outcomes
The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests
Time frame: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline
Time frame: At 2 hour following study drug administration
Safety assessments based on Atrioventricular interval (AVI) and change from baseline
Time frame: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Wenckebach cycle length (WCL) and change from baseline
Time frame: At 1, 2, and 4 hours following study drug administration
Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline
Time frame: At 1, 2, and 4 hours following study drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-919373 and Sotalol in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker (time frame: At 0.5, 1, 2, and 4 hours following study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.