Recent Updates
Recently added Catalysts

Eicosapentaenoic acid-ethyl

Phase 3

Hypertriglyceridemia | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Sep 20, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment1,114
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01350973Efficacy of TAK-085 in Participants With HypertriglyceridemiaPHASE3 COMPLETED 611 — — Nov 1, 2009Dec 1, 2010Sep 20, 2016 - —
NCT01350999Long-term Efficacy and Safety Study of TAK-085 in Participants With HypertriglyceridemiaPHASE3 COMPLETED 503 — — Nov 1, 2009Jan 1, 2011Sep 20, 2016 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percent Change From Baseline in Triglyceride Level at the Final Visit
Baseline and 12 weeks

The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
52 Weeks
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
52 Weeks
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
52 Weeks

Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.

Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
52 Weeks
Secondary Endpoints
Percent Change From Baseline in Triglyceride Level Over Time
Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
Baseline and Weeks 4, 8, 10 and 12
Percent Change From Baseline in Total Cholesterol Over Time
Baseline and Weeks 4, 8, 10 and 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-085 2 gEXPERIMENTALTAK-085 2 g, orally, once daily for up to 12 weeks.
TAK-085 4 gEXPERIMENTALTAK-085 2 g, orally, twice daily for up to 12 weeks.
EPA-E 1.8 gEXPERIMENTALEicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
Interventions
NameTypeDescription
Omega-3-acid ethyl esters 90 (TAK-085)DRUGOmega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
Eicosapentaenoic acid-ethyl (EPA-E)DRUGEPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Eicosapentaenoic acid-ethyl (EPA)DRUGEPA-E capsules
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 74 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one. 2. Participants with differences between 2 values of f...

Unlock Eligibility Criteria