Heart DiseasesPhase 1NCT00162448
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
A Phase 1 study testing BMS-394136 in people with Heart Diseases, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- BMS-394136
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dual-chamber pacemakers or defibrillators
Who cannot join
- Recent acute ischemic events
- Recent atrial or ventricular arrhythmias
- Uncompensated heart failure
- Amiodarone use within last year
- Women of childbearing potential
- QTc <430 msec males
- QTc <450 msec females
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution
Ann Arbor, Michigan
Local Institution
Columbus, Ohio
Local Institution
Salisbury, Maryland
About this study
Official title: Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Conditions
- Heart Diseases
- Being tested
- BMS-394136, Placebo
- Keywords
- Patients requiring dual-chamber pacemakers or defibrillators
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-394136Drug
Oral Solution, Oral, 100 mg, Single dose, 1 day.
PlaceboDrug
Oral Solution, Oral, 0 mg, Single dose, 1 day.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: BMS-394136 |
| A2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary outcomes (4)
Effect of BMS-394136 on atrial vs ventricular refractoriness
Effect of BMS-394136 on the QTc interval
Assess the safety and tolerability of a single dose of BMS-394136
Explore the relationship between plasma concentration of BMS-394136 and refractoriness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162448
- Sponsor's protocol ID
- CV175-003
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2005
- Last updated
- 20 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators
- ClinicalTrials.gov ID
- NCT00162448
- Acronym / sponsor ID
- CV175-003
- Conditions
- Heart Diseases
- Keywords
- Patients requiring dual-chamber pacemakers or defibrillators
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- First posted
- 13 Sep 2005 (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.
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: BMS-394136 |
| A2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with dual-chamber pacemakers or defibrillators
Key exclusion criteria (7 listed)
- Recent acute ischemic events
- Recent atrial or ventricular arrhythmias
- Uncompensated heart failure
- Amiodarone use within last year
- Women of childbearing potential
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-394136Oral Solution, Oral, 100 mg, Single dose, 1 day. | Drug | A1 |
| PlaceboOral Solution, Oral, 0 mg, Single dose, 1 day. | Drug | A2 |
Primary outcome
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
4 secondary outcomes
Effect of BMS-394136 on atrial vs ventricular refractoriness
Effect of BMS-394136 on the QTc interval
Assess the safety and tolerability of a single dose of BMS-394136
Explore the relationship between plasma concentration of BMS-394136 and refractoriness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-394136 in people with Heart Diseases, run by Bristol-Myers Squibb at 3 sites in United States.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 20 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period). 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 20 Aug 2008.