Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

Part of paid clinical trials in Sacramento, California.

Sponsor
Amarin Pharma Inc.
Study ID
NCT01047683
Phase
PHASE3
Status
Completed

Conditions

  • Hypertriglyceridemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMR101 (ethyl icosapentate) - 4 g/day — DRUG
    AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
  • AMR101 (ethyl icosapentate) - 2 g/day — DRUG
    AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
  • Placebo — DRUG
    Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Study Details

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Key Dates

Start date
Dec 31, 2009
Status verified
Mar 2022
Primary completion
Oct 31, 2010
Completion
Jul 31, 2011

Study Design

Enrollment
229 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: AMR101 (ethyl icosapentate) - 2 g/day
  • Experimental: AMR101 (ethyl icosapentate) - 4 g/day

Primary Outcome Measure

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect [ Time Frame: baseline and 12 weeks ]

Locations (18)

FacilityCityStateZIPSite coordinators
Amarin Investigational SiteSacramentoCalifornia95823-
Amarin Investigational SiteGoldenColorado80401-
Amarin Investigational SiteMiamiFlorida33169-
Amarin Investigational SiteMiamiFlorida33183-
Amarin Investigational SiteOcalaFlorida34471-
Amarin Investigational SiteAddisonIllinois27106-
Amarin Investigational SiteChicagoIllinois60611-
Amarin Investigational SiteLouisvilleKentucky40213-
Amarin Investigational SiteButteMontana59701-
Amarin Investigational SiteRaleighNorth Carolina27527-
Amarin Investigational SiteWinston-SalemNorth Carolina27103-
Amarin Investigational SiteCincinnatiOhio45212-
Amarin Investigational SiteCincinnatiOhio45219-
Amarin Investigational SiteLyndhurstOhio44124-
Amarin Investigational SiteTulsaOklahoma74136-
Amarin Investigational SiteCorpus ChristiTexas78404-
Amarin Investigational SiteHoustonTexas77030-
Amarin Investigational SiteRichmondVirginia23294-

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Amarin Investigational Site· Sacramento, CAAmarin Investigational Site· Golden, COAmarin Investigational Site· Miami, FLAmarin Investigational Site· Ocala, FLAmarin Investigational Site· Addison, ILAmarin Investigational Site· Chicago, IL

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