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Niacin /Simvastatin

Phase 3

Hyperlipidemia | Small molecule | Metabolic |Abbott Laboratories|Last Updated: Jun 13, 2011

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment199
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00465088An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)PHASE3 COMPLETED 199 — — Apr 1, 2007 -Jun 13, 201146 United States
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Study Endpoints
Primary Endpoints
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
From baseline to Week 12

(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Secondary Endpoints
Percent Change in HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 12
From baseline to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
Niacin ER/Simvastatin TabletsDRUGUp to 2000 mg/40 mg at bedtime
atorvastatinDRUG40 mg at bedtime
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Subjects must meet all of the following laboratory criteria: * HDL-C \<40 mg/dL for men and \<50 mg/dL for women. * LDL-C ≥130 mg/dL but \<250 mg/dL. * TG \<350 mg/dL. * Creatine phosphokinase (CPK) \< 3 x upper limit of normal (ULN). * Alanine aminotransferase (ALT...

Countries:United States
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