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torcetrapib/atorvastatin

Phase 3

Hyperlipidemia | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Feb 17, 2012

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 Trials4
Total Enrollment5,468
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00267254A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.PHASE3 COMPLETED 640Jan 1, 2006Aug 1, 2006Nov 21, 200749 United States
NCT00139061Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. FenofibratePHASE3 COMPLETED 128Mar 1, 2005May 1, 2006Oct 31, 200726 France
NCT00137462Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.PHASE3 COMPLETED 900Nov 1, 2004Sep 1, 2006Nov 16, 200759 United States, Canada
NCT00138762A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High CholesterolPHASE3 COMPLETED 3,800Jul 1, 2004Aug 1, 2006Feb 17, 2012154 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.
LDL and HDL levels
Secondary Endpoints
Changes in other lipid parameters and other biomarkers.
Changes in levels of lipid parameters and other biomarkers
Changes in levels of lipids and other biomarkers.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
torcetrapib/atorvastatinDRUG -
simvastatinDRUG -
FenofibrateDRUG -
atorvastatinDRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * eligible for statin treatment for LDL cholesterol by NCEP guidelines Exclusion Criteria: * Women who are pregnant or lactating, or planning to become pregnant. * Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA r...

Countries:United StatesFranceCanadaBelgiumGermanyMexicoNorwaySouth KoreaSwedenUnited Kingdom
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