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Niaspan

Phase 1

Dyslipidemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Oct 12, 2015

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01071291Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)PHASE1 COMPLETED 37Feb 1, 2010Sep 1, 2010Oct 12, 2015 -
NCT01104519A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)PHASE1 COMPLETED 12Mar 1, 2008Jul 1, 2008Jul 30, 2015 -
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Study Endpoints
Primary Endpoints
Change from baseline in cholesterol efflux
Baseline and 12 weeks
Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Baseline and 6 weeks
flow-mediated dilation (FMD) of brachial artery
predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery
predose, 4 hours post dose and 24 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALArm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2
Arm BEXPERIMENTALArm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2
1EXPERIMENTALNiaspan - Placebo
2EXPERIMENTALPlacebo - Niaspan
Interventions
NameTypeDescription
NiaspanDRUGNiaspan™
Comparator: PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy Male Subjects Exclusion Criteria : * Subject has a history of stroke, chronic seizures, or major neurological disorder * Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respira...

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