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torcetrapib/atorvastatin

Phase 3

Coronary Disease | Small molecule | Cardiovascular |Pfizer, Inc.|Trials Updated: Apr 22, 2015

torcetrapib/atorvastatin development status

Highest phase Phase 3
Registered trials 14 across 1 sponsor since Aug 2005

torcetrapib/atorvastatin target and mechanism

Molecular targetCETP
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials9
Total Enrollment7,958

FDA Designations

No designations recorded

torcetrapib/atorvastatin clinical trials

torcetrapib/atorvastatin · 9 trials · 8 indications

Phase 3 9
NCT00267254A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.Hyperlipidemia
COMPLETED640 Analytics
NCT00134485Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial HypercholerolemiaHypercholesterolemia, Familial
COMPLETED400 Analytics
NCT00134511Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol DisorderHypercholesterolemia, Familial
COMPLETED30 Analytics
NCT00139061Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. FenofibrateHyperlipidemia
COMPLETED128 Analytics
NCT00134498A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High TriglyceridesHypertriglyceridemia
COMPLETED160 Analytics
NCT00137462Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.Hyperlipidemia
COMPLETED900 Analytics
NCT00138762A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High CholesterolHyperlipidemia
COMPLETED3,800 Analytics
NCT00136981Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.Hypercholesterolemia, Familial
COMPLETED800 Analytics
NCT00134173A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart DiseaseCoronary Disease
COMPLETED1,100 Analytics
PHASE3COMPLETED
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.
HyperlipidemiaUnlock trial analytics
PHASE3COMPLETED
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Hypercholesterolemia, FamilialUnlock trial analytics
PHASE3COMPLETED
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
Hypercholesterolemia, FamilialUnlock trial analytics
PHASE3COMPLETED
Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
HyperlipidemiaUnlock trial analytics
PHASE3COMPLETED
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
HypertriglyceridemiaUnlock trial analytics
PHASE3COMPLETED
Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.
HyperlipidemiaUnlock trial analytics
PHASE3COMPLETED
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
HyperlipidemiaUnlock trial analytics
PHASE3COMPLETED
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
Hypercholesterolemia, FamilialUnlock trial analytics
PHASE3COMPLETED
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Coronary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Change in HDL-C and LDL-C
Change in LDL-C and HDL-C
To assess HDL-C increase and non-HDL lowering effect of torcetrapib/atorvastatin vs. fenofibrate.
Change in HDL-C and non-HDL-C levels
Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.
LDL and HDL levels
Change in intima media thickness as measures by carotid ultrasound
Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Endpoints

Changes in other lipid parameters and other biomarkers.
Changes in other lipid parameters
Other lipid variables
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
torcetrapib/atorvastatinDRUG -
simvastatinDRUG -
atorvastatinDRUG -
FenofibrateDRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 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 StatesAustraliaCanadaDenmarkFranceIcelandNorwaySouth AfricaSwedenBelgiumGermanyMexicoSouth KoreaUnited KingdomCzechiaFinlandItalyNetherlandsPolandSpain
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Frequently asked questions about torcetrapib/atorvastatin

What is torcetrapib/atorvastatin?

Torcetrapib/atorvastatin is an investigational combination small molecule developed by Pfizer for cardiovascular conditions. It pairs torcetrapib, a CETP inhibitor, with atorvastatin, a statin used to lower cholesterol. It was studied in coronary disease, hypercholesterolemia, familial hyperlipidemia, hyperlipidemia, and hypertriglyceridemia, and remains in Phase 3 development.

What does torcetrapib/atorvastatin target?

Torcetrapib/atorvastatin targets CETP, cholesteryl ester transfer protein. Torcetrapib acts as a CETP inhibitor, while atorvastatin is a statin component that lowers cholesterol. The combination was designed to raise HDL cholesterol through CETP inhibition while lowering LDL cholesterol through the atorvastatin component.

Who makes torcetrapib/atorvastatin?

Pfizer, Inc. develops torcetrapib/atorvastatin. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 3 clinical program evaluating the combination in patients with high cholesterol and related lipid disorders.

What phase is torcetrapib/atorvastatin in?

Torcetrapib/atorvastatin is in Phase 3 development. It is an investigational combination and is not approved. Four Phase 3 trials have been completed, with no active trials ongoing. The completed studies enrolled a total of 5,468 participants across the program.

What clinical trials is torcetrapib/atorvastatin in?

Four completed Phase 3 trials studied torcetrapib/atorvastatin. NCT00267254 compared it with simvastatin in 640 subjects with high cholesterol. NCT00139061 assessed HDL-C increase and non-HDL lowering versus fenofibrate in 128 subjects in France. NCT00138762 compared it with atorvastatin alone or placebo in 3,800 patients. NCT00137462 compared it with atorvastatin alone in 900 patients.

What is torcetrapib/atorvastatin used for?

Torcetrapib/atorvastatin was studied for coronary disease, hypercholesterolemia, familial hyperlipidemia, hyperlipidemia, and hypertriglyceridemia. The Phase 3 trials enrolled adults with high cholesterol and lipid disorders, comparing the combination against simvastatin, fenofibrate, atorvastatin alone, or placebo.