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A-002

Phase 4FDA approved

Coronary Artery Disease | Small Molecules | Cardiovascular |Anthera Pharmaceuticals, Inc.|Trials Updated: Feb 2, 2010

A-002 development status

FDA approval on record Jul 10, 1998 as Lipitor
Approval holderUpjohn
ApplicationNDA020702
Highest phase Phase 4 run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (NCT00844376)
Phase scored for ANTHPhase 2
Registered trials 182 across 42 sponsors since Aug 2001

Label indication LIPITOR is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization…

A-002 target and mechanism

ModalitySmall Molecules

Also known as Varespladib Methyl (A-002), Varespladib, Lipitor, Atorvastatin

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment520

FDA Designations

No designations recorded

A-002 clinical trials

A-002 · 2 trials · 2 indications

Phase 2 2
NCT00525954PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery DiseaseCoronary Artery Disease
COMPLETED120 Analytics
NCT00455546PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery DiseaseCoronary Artery Disease (CAD)
COMPLETED400 Analytics
PHASE2COMPLETED
PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease
Coronary Artery Disease
NCT00525954120
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PHASE2COMPLETED
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
Coronary Artery Disease (CAD)
NCT00455546400
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Study Endpoints

Primary Endpoints

The primary objective of this study is to determine the effect of once daily (QD) dosing of A-002 on sPLA2 levels and activity
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.

Secondary Endpoints

Determine the effect of QD dosing of A-002 on sPLA2 levels and activity at each time point (Weeks 2, 4, and 8)
Compare the effect of QD dosing of A-002 on sPLA2 enzyme levels and markers of inflammation
Determine plasma drug concentrations with QD dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
A-002DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: Subjects are eligible for inclusion if they meet the following inclusion criteria: 1. Men and women ≥18 years of age 2. Written informed consent from the subject 3. Stable CAD 4. Stable medical condition, will be compliant and able to comply with the requirements of the protoco...

Countries:United StatesUkraine
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Competitive Landscape -Coronary Artery Disease 151 trials

Top 10 of 23 competitors

CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS7PHASE3Inclisiran, YMI024
Novo Nordisk A/S Sponsored ADR Class BNVO4PHASE3Ziltivekimab
Alnylam Pharmaceuticals, IncALNY1PHASE3Zilebesiran
Viatris, Inc.VTRS1PHASE3Selatogrel
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib+ ezetimibe daily
GE Healthcare Technologies Inc.GEHC3PHASE2Regadenoson
Humacyte, Inc.HUMA1PHASE2CTEV
AstraZeneca PLCAZN1 - Tezepelumab
BayerBAYRY1PHASE1Nurandociguat
Hoffmann-La RocheRHHBY1PHASE1RO7763505
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