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BMS-394136

Phase 1

Heart Diseases | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Aug 20, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

BMS-394136 · 1 trial · 1 indication

Phase 1 1
NCT00162448A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or DefibrillatorsHeart Diseases
COMPLETED36 Analytics
PHASE1COMPLETED
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
Heart DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
A1EXPERIMENTAL -
A2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-394136DRUGOral Solution, Oral, 100 mg, Single dose, 1 day.
PlaceboDRUGOral Solution, Oral, 0 mg, Single dose, 1 day.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with dual-chamber pacemakers or defibrillators Exclusion Criteria: * 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 * QT...

Countries:United States
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Frequently asked questions about BMS-394136

What is BMS-394136 used for?

BMS-394136 is an investigational small molecule being developed for heart diseases. It is being studied for its electrophysiologic effects on the atrium and ventricle in patients with dual-chamber pacemakers or defibrillators. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-394136?

BMS-394136 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's safety and effects in patients with heart diseases.

What phase is BMS-394136 in?

BMS-394136 is in Phase 1 clinical development. A Phase 1 study has been completed, which assessed the drug's electrophysiologic effects on the atrium and ventricle in patients with dual-chamber pacemakers or defibrillators. The drug is investigational and has not been approved by the FDA.

What clinical trials is BMS-394136 in?

BMS-394136 has one completed clinical trial registered as NCT00162448. This Phase 1 study assessed the electrophysiologic effects of the drug on the atrium and ventricle in patients with dual-chamber pacemakers or defibrillators. The trial enrolled 36 participants in the United States and was placebo-controlled and double-blind.

Is BMS-394136 the same as any other drug?

No alternative names for BMS-394136 have been disclosed. The drug is identified by its development code BMS-394136 and is being studied by Bristol-Myers Squibb. It is a small molecule intended for the treatment of heart diseases, currently in early-stage clinical investigation.