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KAI-9803

Phase 2

Myocardial Infarction | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Sep 2, 2011

KAI-9803 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,180

FDA Designations

No designations recorded

KAI-9803 clinical trials

KAI-9803 · 1 trial · 3 indications

Phase 2 1
NCT00785954Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]Myocardial Infarction
COMPLETED1,180 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Myocardial Infarction
NCT007859541,180
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Study Endpoints

Primary Endpoints

The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
During the index hospitalization

Secondary Endpoints

The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Within the first 3 months after Myocardial Infarction
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1: KAI-9803EXPERIMENTAL -
A2: KAI-9803EXPERIMENTAL -
A3: KAI-9803EXPERIMENTAL -
A4: PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
KAI-9803DRUGSTEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites126

Inclusion Criteria: * Acute STEMI and has a planned emergent primary PCI procedure * Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset Exclusion Criteria: * Persistent systolic blood pressure \< 90 mm Hg

Countries:United StatesAustraliaBelgiumCanadaCzechiaDenmarkFinlandGermanyHungaryIsraelItalyNetherlandsNew ZealandNorwayPolandPortugalSpainSweden
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