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MK0653, ezetimibe

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |Organon & Co.|Last Updated: Aug 15, 2024

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-BlindUNCONTROLLEDBiomarker
Total Trials9
Total Enrollment6,322
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00457275Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)PHASE3 COMPLETED 440Apr 1, 2005Nov 1, 2005Aug 15, 2024 -
NCT00395473Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)PHASE3 COMPLETED 141Mar 1, 2005Nov 1, 2005May 10, 2024 -
NCT00092612Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)PHASE3 COMPLETED 372May 1, 2003Jun 1, 2004Aug 15, 2024 -
NCT00092638An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)PHASE3 COMPLETED 450May 1, 2003Aug 1, 2004Aug 15, 2024 -
NCT00092573Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)PHASE3 COMPLETED 576Apr 1, 2003Nov 1, 2004Aug 15, 2024 -
NCT00092625Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)PHASE3 COMPLETED 442Mar 1, 2003Aug 1, 2004Aug 15, 2024 -
NCT00092599Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)PHASE3 COMPLETED 410Feb 1, 2003Jul 1, 2004Aug 15, 2024 -
NCT00092560Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)PHASE3 COMPLETED 587Dec 1, 2002Dec 1, 2003Aug 15, 2024 -
NCT00092586Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)PHASE3 COMPLETED 2,904Sep 1, 2002Oct 1, 2003Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
Approval
Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Tolerability
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Plasma LDL-C vs. fenofibrate for 12 weeks.
Percent change in LDL-C
Secondary Endpoints
Safety and tolerability.
Plasma LDL-C, HDL-C and triglycerides after 12 weeks.
All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
MK0653, ezetimibe / Duration of Treatment: 4 WeeksDRUG -
MK0653, ezetimibe / Duration of Treatment: 6 WeeksDRUG -
MK0653, ezetimibeDRUG -
Comparator: ezetimibe, placeboDRUG -
Comparator: fenofibrate monotherapyDRUG -
Comparator: statinsDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Men or women \>18 and \<80 years of age * Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1 * Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintain...

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