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varespladib methyl

Phase 3

Acute Coronary Syndrome | Small Molecules | Cardiovascular |Anthera Pharmaceuticals, Inc.|Trials Updated: Mar 4, 2014

varespladib methyl development status

Highest phase Phase 3 (NCT01130246)
Phase scored for ANTHPhase 2
Registered trials 3 across 1 sponsor since May 2010

varespladib methyl target and mechanism

Molecular targetPLA2G2A
Target classInhibitor
ModalitySmall Molecules
ChEMBLCHEMBL148674

Also known as Varespladib Methyl (A-002)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment625

FDA Designations

No designations recorded

varespladib methyl clinical trials

varespladib methyl · 1 trial · 1 indication

Phase 2 1
NCT00743925FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary SyndromesAcute Coronary Syndrome
COMPLETED625 Analytics
PHASE2COMPLETED
FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes
Acute Coronary Syndrome
NCT00743925625
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Study Endpoints

Primary Endpoints

Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups.
8 Weeks

Secondary Endpoints

The occurrence of MACEs will be examined for any treatment-related trends at study completion.
End of Study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORA-002 (500 mg QD) plus Atorvastatin (80 mg QD)
2PLACEBO_COMPARATORMatching Placebo tablets plus Atorvastatin (80 mg QD)

Interventions

NameTypeDescription
Varespladib Methyl (A-002)DRUG2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Men and women ≥18 years of age * A diagnosis of unstable angina, NSTEMI, or STEMI * Any one of the following criteria: Diabetes, CRP ≥2 mg/L, or metabolic syndrome * Subjects must be randomized within 96 hours of the index event * Percutaneous revascularization, if required or...

Countries:GeorgiaRussiaUkraine
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