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simvastatin ezetimibe

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |Organon & Co.|Last Updated: May 16, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

simvastatin ezetimibe · 1 trial · 1 indication

Phase 3 1
NCT00496730A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)Hypercholesterolemia
COMPLETED256 Analytics
PHASE3COMPLETED
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Hypercholesterolemia
NCT00496730256
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Study Endpoints

Primary Endpoints

Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
Baseline and 8 Weeks

Secondary Endpoints

Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
Baseline and 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Vytorin®EXPERIMENTALsimvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
atorvastatinACTIVE_COMPARATORatorvastatin 10 mg; tablet, once daily, 8 Weeks

Interventions

NameTypeDescription
simvastatin (+) ezetimibeDRUGsimvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
Comparator: atorvastatinDRUGatorvastatin 10 mg; tablet, once daily, 8 Weeks
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Eligibility Criteria

Age Range20 Years to 79 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement * No history of diabetes and 100 \<=LDL-C \<=250 mg/dl Exclusion Criteria: * Myocardial Infarction, coronary artery bypa...

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Competitive Landscape -Dyslipidemia / Hypercholesterolemia 39 trials (matched to "Hypercholesterolemia")

CompanyTickerTrialsLead PhaseDrugs
Arrowhead Pharmaceuticals, Inc.ARWR7PHASE3zodasiran
Novartis AG Sponsored ADRNVS11PHASE3inclisiran
Merck & Co., Inc.MRK3PHASE3Enlicitide Decanoate
AstraZeneca PLCAZN1PHASE3AZD0780
Ionis Pharmaceuticals, Inc.IONS1PHASE3Olezarsen
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Alirocumab
Eli Lilly and CompanyLLY1PHASE2Solbinsiran
MediciNova, Inc.MNOV1PHASE2MN-001
NewAmsterdam Pharma Company N.V.NAMS1PHASE1Obicetrapib
Verve Therapeutics, Inc.VERV3PHASE1VERVE-102
CRISPR Therapeutics AGCRSP1PHASE1CTX310
Esperion Therapeutics, Inc.ESPR1 - Bempedoic Acid
Ultragenyx Pharmaceutical, Inc.RARE1 - Undisclosed
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