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RO4905417

Phase 2

Coronary Heart Disease, Graft Occlusion, Vascular | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment384

FDA Designations

No designations recorded

Clinical trial landscape

RO4905417 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT01327183A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary InterventionMyocardial Infarction
COMPLETED532 Analytics
NCT01245634A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) SurgeryCoronary Heart Disease, Graft Occlusion, Vascular
COMPLETED384 Analytics
PHASE2COMPLETED
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
Myocardial Infarction
NCT01327183532
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PHASE2COMPLETED
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Coronary Heart Disease, Graft Occlusion, Vascular
NCT01245634384
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Study Endpoints

Primary Endpoints

Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
from baseline to 24 hours post PCI
Proportion of patients with diameter stenosis >50% (including total occlusion) of at least one saphenous vein graft, as assessed by invasive angiography
1 year
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.
Throughout study

Secondary Endpoints

Change from baseline in troponin I at 8 hours post PCI
from baseline to 8 hours post PCI
Peak and AUC for troponin I
24 hours post PCI
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
from baseline to 24 hours post PCI
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
20 mg/kg RO4905417 before PCIEXPERIMENTAL -
5 mg/kg RO4905417 before PCIEXPERIMENTAL -
Placebo before PCIPLACEBO_COMPARATOR -
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -
1EXPERIMENTAL -
10PLACEBO_COMPARATOR -
11EXPERIMENTAL -
12PLACEBO_COMPARATOR -
2PLACEBO_COMPARATOR -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
5EXPERIMENTAL -
6PLACEBO_COMPARATOR -
7EXPERIMENTAL -
8PLACEBO_COMPARATOR -
9EXPERIMENTAL -

Interventions

NameTypeDescription
Percutaneous Coronary Intervention (PCI)PROCEDUREat least 1 hour and up to 24 hours after completion of drug infusion
RO4905417DRUG5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
placeboDRUGiv infusion, completed at least 1 hour and up to 24 hours before PCI
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Eligibility Criteria

Age Range19 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Adult patients, \>18 to \<75 years of age * Non ST-elevation myocardial infarction * Woman of childbearing potential will be allowed only if using two acceptable methods of contraception * Body mass index (BMI) \</= 40 kg/m2 Exclusion Criteria: * Acute ST-elevation myocardia...

Countries:United StatesCanadaNetherlandsPolandAustralia
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Frequently asked questions about RO4905417

What is RO4905417 used for?

RO4905417 is an investigational small molecule being developed by Roche Holding AG for cardiovascular conditions, including coronary heart disease, graft occlusion, vascular issues, myocardial infarction, and peripheral arterial disease (PAD). It has been studied in patients undergoing coronary artery bypass graft surgery and in those with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention.

Who makes RO4905417?

RO4905417 is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. The drug is an investigational small molecule in Phase 2 clinical development for cardiovascular indications.

What phase is RO4905417 in?

RO4905417 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including studies in healthy volunteers, patients with peripheral arterial disease, and patients undergoing coronary artery bypass graft surgery or percutaneous coronary intervention for myocardial infarction.

What clinical trials is RO4905417 in?

RO4905417 has been studied in three completed clinical trials: NCT00760565, a Phase 1 multiple ascending dose study in healthy volunteers and PAD patients; NCT01245634, a Phase 2 study in patients undergoing CABG surgery; and NCT01327183, a Phase 2 study in patients with non-STEMI undergoing PCI. All trials are completed.

Is RO4905417 FDA approved?

RO4905417 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development and has not been approved for any use.

How does RO4905417 work?

RO4905417 is a small molecule being studied for its effects in cardiovascular diseases. Its specific molecular target has not been disclosed in available clinical trial information, so its mechanism of action is not publicly detailed.