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torcetrapib/atorvastatin

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,100

FDA Designations

No designations recorded

Clinical trial landscape

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.
Hyperlipidemia
NCT00267254640
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PHASE3COMPLETED
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Hypercholesterolemia, Familial
NCT00134485400
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PHASE3COMPLETED
Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Patients With Genetic High Cholesterol Disorder
Hypercholesterolemia, Familial
NCT0013451130
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PHASE3COMPLETED
Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate
Hyperlipidemia
NCT00139061128
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PHASE3COMPLETED
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
Hypertriglyceridemia
NCT00134498160
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PHASE3COMPLETED
Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.
Hyperlipidemia
NCT00137462900
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PHASE3COMPLETED
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
Hyperlipidemia
NCT001387623,800
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PHASE3COMPLETED
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
Hypercholesterolemia, Familial
NCT00136981800
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PHASE3COMPLETED
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Coronary Disease
NCT001341731,100
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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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Competitive Landscape -Coronary Artery Disease 99 trials (matched to "Coronary Disease")

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO5PHASE3Ziltivekimab
Novartis AG Sponsored ADRNVS4PHASE3Inclisiran
Boston Scientific CorporationBSX8PHASE3Undisclosed
Alnylam Pharmaceuticals, IncALNY1PHASE3Zilebesiran
Viatris, Inc.VTRS1PHASE3Selatogrel
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib, ezetimibe daily
GE Healthcare Technologies Inc.GEHC3PHASE1Regadenoson
Abbott LaboratoriesABT13 - Undisclosed
HeartFlow, Inc.HTFL5 - Undisclosed
Medtronic PlcMDT3N/AUndisclosed
Teleflex IncorporatedTFX2N/AUndisclosed
AstraZeneca PLCAZN1 - Tezepelumab
BioCardia, Inc.BCDA1N/AUndisclosed
Orchestra BioMed Holdings, Inc.OBIO1N/AUndisclosed
Sanofi SA Sponsored ADRSNY1 - alirocumab/2week, statin ± ezetimibe
Johnson & JohnsonJNJ1N/AUndisclosed
Rhythm Pharmaceuticals, Inc.RYTM2N/AUndisclosed
Healthcare Services Group, Inc.HCSG1 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1 - Flozin
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Frequently asked questions about torcetrapib/atorvastatin

What is torcetrapib/atorvastatin used for?

Torcetrapib/atorvastatin is an investigational combination therapy studied for hypertriglyceridemia, hypercholesterolemia, familial hyperlipidemia, hyperlipidemia, and coronary disease. It is a small molecule developed by Pfizer for cardiovascular conditions. All four Phase 3 trials have been completed, and the drug is not approved.

Who makes torcetrapib/atorvastatin?

Pfizer, Inc. (NYSE: PFE) develops torcetrapib/atorvastatin. The company conducted four Phase 3 clinical trials of the combination therapy for cardiovascular indications including hyperlipidemia and coronary disease. All trials are completed, and the drug remains investigational.

What phase is torcetrapib/atorvastatin in?

Torcetrapib/atorvastatin is in Phase 3 clinical development. Pfizer completed four Phase 3 trials with a total enrollment of 5,468 participants. The trials studied the combination in patients with high cholesterol, high triglycerides, and coronary disease. The drug is not FDA approved.

What clinical trials is torcetrapib/atorvastatin in?

Torcetrapib/atorvastatin has completed four Phase 3 trials: NCT00134173 (coronary IVUS study, 1,100 patients), NCT00134498 (high triglycerides, 160 patients), NCT00137462 (hyperlipidemia, 900 patients), and NCT00267254 (high cholesterol, 640 patients). All trials are completed with no active studies.

Is torcetrapib/atorvastatin the same as atorvastatin?

Torcetrapib/atorvastatin is a combination product containing atorvastatin plus torcetrapib. Clinical trials compared this combination to atorvastatin alone in patients with coronary disease, high triglycerides, and hyperlipidemia. The combination is distinct from atorvastatin monotherapy.