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CRESTOR

Phase 3

Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Nov 19, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment5,013
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00206310Crestor Versus Placebo in Subjects With Heart FailurePHASE3 COMPLETED 5,013 — — Sep 1, 2003Jul 1, 2007Nov 19, 2010375 Belgium, Bulgaria +19
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Study Endpoints
Primary Endpoints
The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).
Secondary Endpoints
The secondary objectives are to evaluate the effects of rosuvastatin on:
Total mortality
Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
CRESTORDRUG -
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites375

Inclusion Criteria: * Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator Exclusion Criteria: * Acute myocardial infarction within 6 months before randomizatio...

Countries:BelgiumBulgariaCzechiaDenmarkFinlandFranceGermanyHungaryIrelandNetherlandsNorwayPolandPortugalRomaniaRussiaSlovakiaSouth AfricaSpainSwedenSwitzerlandUnited Kingdom
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Competitive Landscape -Heart Failure 115 trials
CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO8PHASE3NNC0487-0111, Ziltivekimab, Tocilizumab, Dobutamine, NaCl 0.9%
AstraZeneca PLCAZN6PHASE3Baxdrostat and dapagliflozin
Cytokinetics, IncorporatedCYTK2PHASE3Omecamtiv Mecarbil, CK-4021586
Amgen Inc.AMGN1PHASE3Maridebart cafraglutide
Pfizer Inc.PFE1PHASE2Low Dose PF-07328948
DexCom, Inc.DXCM1PHASE3Sotagliflozin
Merck & Co., Inc.MRK1PHASE2Vericiguat
Bristol-Myers Squibb CompanyBMY1PHASE2BMS-986435
Novartis AG Sponsored ADRNVS3PHASE1HJB647 low dose
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
BioCardia, Inc.BCDA2PHASE1CardiALLO Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells
Edwards Lifesciences CorporationEW10NAOptimal Medical Therapy
ICON PlcICLR1PHASE2JTT-861
Medtronic PlcMDT5 — Undisclosed
Abbott LaboratoriesABT8NAUndisclosed
Illumina, Inc.ILMN1PHASE218F-metaFluorobenzylguanidine, Rubidium-82
Boston Scientific CorporationBSX3NAUndisclosed
Moderna, Inc.MRNA1 — Undisclosed
CVRx, Inc.CVRX2 — Undisclosed
Windtree TherapeuticsWINT1PHASE1Istaroxime
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