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MK0524A, /Duration of Treatment : 8 Weeks

Phase 3

Flushing | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 17, 2017

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 Trials2
Total Enrollment495
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00533611Effect of MK0524A on Flushing Caused by Niacin (0524A-056)PHASE3 COMPLETED 330 — — Apr 1, 2007Aug 1, 2007Feb 17, 2017 - —
NCT00533676Endpoint Validation Study (0524A-015)PHASE2 COMPLETED 165 — — Aug 1, 2004Dec 1, 2006Feb 17, 2017 - —
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Study Endpoints
Primary Endpoints
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.
Over 1 week
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
8 weeks
Secondary Endpoints
MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).
Daily
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0524A, /Duration of Treatment : 4 WeeksDRUG -
Comparator : niacin /Duration of Treatment : 1 WeeksDRUG -
MK0524A, /Duration of Treatment : 8 WeeksDRUG -
Comparator : placebo (unspecified) /Duration of Treatment : 8 WeeksDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: * Patient has a history of hypersensitivity to niacin or niacin-containing p...

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