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AMR101 - /day

Phase 3

Hypertriglyceridemia | Small molecule | Metabolic |Amarin Corporation plc|Last Updated: Apr 25, 2022

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment931
FDA Designations
No designations recorded
Clinical trial landscape

AMR101 - /day · 2 trials · 1 indication

Phase 3 2
NCT01047501Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)Hypertriglyceridemia
COMPLETED702 Analytics
NCT01047683Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dLHypertriglyceridemia
COMPLETED229 Analytics
PHASE3COMPLETED
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Hypertriglyceridemia
NCT01047501702
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PHASE3COMPLETED
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Hypertriglyceridemia
NCT01047683229
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Study Endpoints
Primary Endpoints
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
baseline and 12 weeks

Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Secondary Endpoints
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
baseline and 12 weeks
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
baseline and 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
AMR101 (ethyl icosapentate) - 2 g/dayEXPERIMENTAL -
AMR101 (ethyl icosapentate) - 4 g/dayEXPERIMENTAL -
Interventions
NameTypeDescription
AMR101 (ethyl icosapentate) - 4 g/dayDRUGAMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
AMR101 (ethyl icosapentate) - 2 g/dayDRUGAMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
PlaceboDRUGPlacebo 4 capsules/day for 12 weeks
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites80

Inclusion Criteria: * Men and women, ages \>18 * Fasting triglyceride ≥200 mg/dL and \<500 mg/dL * LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL * High risk for coronary heart disease * On stable dose of statin (atorvastatin, rosuvastatin or simvastatin) * Provide written ...

Countries:United StatesDenmarkFinlandGermanyIndiaItalyMexicoNetherlandsRussiaSouth AfricaUkraine
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