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

PHASE3CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

July 31, 2011

Conditions
Hypertriglyceridemia
Interventions
DRUG

AMR101 (ethyl icosapentate) - 4 g/day

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)

DRUG

AMR101 (ethyl icosapentate) - 2 g/day

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)

DRUG

Placebo

Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Trial Locations (60)

157

Amarin Investigational Site, Pretoria

1307

Amarin Investigational Site, Dresden

2113

Amarin Investigational Site, Johannesburg

2193

Amarin Investigational Site, Parktown

2730

Amarin Investigational Site, Herlev

3680

Amarin Investigational Site, Kiev

4114

Amarin Investigational Site, Kyiv

6700

Amarin Investigational Site, Mexico City

7129

Amarin Investigational Site, Somerset West

7500

Amarin Investigational Site, Cape Town

9000

Amarin Investigational Site, Aalborg

9301

Amarin Investigational Site, Bloemfontein

11650

Amarin Investigational Site, Mexico City

23294

Amarin Investigational Site, Richmond

27103

Amarin Investigational Site, Winston-Salem

27106

Amarin Investigational Site, Addison

27527

Amarin Investigational Site, Raleigh

33169

Amarin Investigational Site, Miami

33183

Amarin Investigational Site, Miami

34471

Amarin Investigational Site, Ocala

35392

Amarin Investigational Site, Giessen

39120

Amarin Investigational Site, Magdeburg

40213

Amarin Investigational Site, Louisville

44124

Amarin Investigational Site, Lyndhurst

44600

Amarin Investigational Site, Guadalajara, Jalisco

45212

Amarin Investigational Site, Cincinnati

45219

Amarin Investigational Site, Cincinnati

59701

Amarin Investigational Site, Butte

60611

Amarin Investigational Site, Chicago

64460

Amarin Investigational Site, Monterrey Nuevo Leon

65059

Amarin Investigational Site, Odesa

74136

Amarin Investigational Site, Tulsa

76018

Amarin Investigational Site, Ivano-Frankivsk

77030

Amarin Investigational Site, Houston

78404

Amarin Investigational Site, Corpus Christi

80336

Amarin Investigational Site, München

80401

Amarin Investigational Site, Golden

81377

Amarin Investigational Site, München

90127

Amarin Investigational Site, Palermo

90402

Amarin Investigational Site, Nuremberg

95823

Amarin Investigational Site, Sacramento

121552

Amarin Investigational Site, Moscow

129090

Amarin Investigational Site, Moscow

194291

Amarin Investigational Site, Saint Petersburg

197341

Amarin Investigational Site, Saint Petersburg

198205

Amarin Investigational Site, Saint Petersburg

452010

Amarin Investigational Site, Indore

560003

Amarin Investigational Site, Bangalore

560010

Amarin Investigational Site, Bangalore

560054

Amarin Investigational Site, Bangalore

600086

Amarin Investigational Site, Gopālapuram

FI-90014

Amarin Investigational Site, Oulu

380 015

Amarin Investigational Site, Ahmedabad

570 020

Amarin Investigational Site, Mysore

I-16132

Amarin Investigational Site, Genova

1105 AZ

Amarin Investigational Site, Amsterdam

9711 SG

Amarin Investigational Site, Groningen

3021 HC

Amarin Investigational Site, Rotterdam

3045 PM

Amarin Investigational Site, Rotterdam

3584 CX

Amarin Investigational Site, Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amarin Pharma Inc.

INDUSTRY