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MK0733 / Duration of Treatment: 18 Weeks

Phase 3

HDL Cholesterol | 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00389896A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)PHASE3 COMPLETED 150Jul 26, 2001Oct 4, 2002Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
HDL-C raising effects after 6 weeks
6 weeks
Secondary Endpoints
Effect on other lipids and lipoproteins at 6 weeks
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
MK0733 / Duration of Treatment: 18 WeeksDRUG -
Comparator: placebo (unspecified) / Duration of Treatment: 18 WeeksDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient has stable Type 2 diabetes mellitus at Visit 1. * Patient meets screening criteria based on Visit 1 lab tests Exclusion Criteria: * Patient is pregnant, breastfeeding, or at risk of becoming pregnant * Patient has heart disease, uncontrolled high blood pressure, or o...

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