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Fixed Combination of Fenofibrate/simvastatin 145

Phase 3

Dyslipidemia | Small molecule | Cardiovascular |Abbott Laboratories|Last Updated: Dec 11, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment575

FDA Designations

No designations recorded

Clinical trial landscape

Fixed Combination of Fenofibrate/simvastatin 145 · 1 trial · 1 indication

Phase 3 1
NCT01674712A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular DiseaseDyslipidemia
COMPLETED575 Analytics
PHASE3COMPLETED
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
Dyslipidemia
NCT01674712575
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Study Endpoints

Primary Endpoints

Percentage of Change of TG (Triglyceride)
from baseline to 12 weeks of treatment

Collection and measurement of blood samples.

Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
from baseline to 12 weeks of treatment

Collection and measurement of blood samples.

Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
from baseline to 12 weeks of treatment

Collection and measurement of blood samples.

Secondary Endpoints

Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
12 weeks
Percentage of TC (Triglyceride) From Baseline
12 weeks
Percentage of Apolipoprotein AI From Baseline
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fenofibrate/simvastatin 145/20 mgEXPERIMENTAL -
Simvastatin 20 mgACTIVE_COMPARATOR -
Fenofibrate 145 mgACTIVE_COMPARATOR -
Fenofibrate/simvastatin 145/40 mgEXPERIMENTAL -
Simvastatin 40 mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Fixed Combination of Fenofibrate/simvastatin 145/20 mgDRUGFenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin 20 mgDRUGSimvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate 145 mgDRUGFenofibrate, tablet, 145 mg, once daily, 12 weeks
Fixed Combination of Fenofibrate/simvastatin 145/40 mgDRUGFenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
Simvastatin 40 mgDRUGsimvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: 1. Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose ...

Countries:ArgentinaCzechiaGermanyMexicoPolandRomaniaRussia
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Competitive Landscape -Dyslipidemia 19 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY2PHASE3Lepodisiran
Merck & Co., Inc.MRK1PHASE3Enlicitide, Rosuvastatin
NewAmsterdam Pharma Company N.V.NAMS3PHASE3obicetrapib, ezetimibe daily
AstraZeneca PLCAZN3PHASE2AZD0780, Rosuvastatin
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-DIMERPA
Novartis AG Sponsored ADRNVS1 - Undisclosed
CRISPR Therapeutics AGCRSP1PHASE1CTX310
HeartFlow, Inc.HTFL1N/ARosuvastatin
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