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TRO40303

Phase 2

Acute Myocardial Infarctus | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Aug 1, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

TRO40303 · 1 trial · 1 indication

Phase 2 1
NCT01374321Safety and Efficacy Study of TRO40303 for Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial InfarctionAcute Myocardial Infarctus
COMPLETED168 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of TRO40303 for Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction
Acute Myocardial InfarctusUnlock trial analytics

Study Endpoints

Primary Endpoints

Infarct size expressed as area under the curve for Creatine kinase and Troponin I
Blood samples will be collected at admission and every 6 hours until 72h

Secondary Endpoints

Infarct size evaluated by Cardiac Magnetic Resonance
A cardiac magnetic resonance between day 3 and Day 5 after balloon inflation
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
TRO40303EXPERIMENTAL -

Interventions

NameTypeDescription
TRO40303DRUG6 mg/kg, peripheral IV, single dose just before balloon inflation, slow bolus (35ml/min)
PlaceboDRUGsingle dose just before balloon inflation by slow bolus (35ml/min, peripheral IV)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Male and Female with non childbearing potential patients 2. Age \> 18 years old 3. First acute myocardial infarction 4. Occlusion should affect the following coronary arteries: LAD,or the dominant or balanced RCA, or the dominant or balanced LCx 5. Acute myocardial infarction...

Countries:DenmarkFranceNorwaySweden
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Frequently asked questions about TRO40303

What is TRO40303 used for?

TRO40303 is an investigational small molecule being studied for the treatment of acute myocardial infarction, commonly known as a heart attack. It is designed to reduce reperfusion injury in patients undergoing percutaneous coronary intervention for acute myocardial infarction. The drug is in Phase 2 clinical development.

Who makes TRO40303?

TRO40303 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The drug is currently in Phase 2 clinical development for the treatment of acute myocardial infarction.

What phase is TRO40303 in?

TRO40303 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is TRO40303 in?

TRO40303 has been studied in one clinical trial, identified as NCT01374321. This Phase 2 study evaluated the safety and efficacy of TRO40303 for reduction of reperfusion injury in patients undergoing percutaneous coronary intervention for acute myocardial infarction. The trial was completed and enrolled 168 participants.

How does TRO40303 work?

TRO40303 is a small molecule designed to reduce reperfusion injury in patients with acute myocardial infarction. Reperfusion injury occurs when blood flow is restored to ischemic heart tissue, potentially causing additional damage. The drug aims to mitigate this damage during percutaneous coronary intervention procedures.