NCT01492361View on ClinicalTrials.gov

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

PHASE3CompletedINTERVENTIONAL
Enrollment

8,179

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Cardiovascular Diseases
Interventions
DRUG

AMR101

Parallel Assignment

DRUG

Placebo

Parallel Assignment

DRUG

Statin therapy

Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)

Trial Locations (410)

1035

Amarin Investigational Site, Witbank

1500

Amarin Investigational Site, Benoni

2013

Amarin Investigational Site, Soweto

2015

Amarin Investigational Site, Camperdown

2480

Amarin Investigational Site, Lismore

3004

Amarin Investigational Site, Melbourne

3065

Amarin Investigational Site, Fitzroy

3081

Amarin Investigational Site, Heidelberg Heights

3112

Amarin Investigational Site, Tauranga

3220

Amarin Investigational Site, Geelong

3240

Amarin Investigational Site, Hamilton

4001

Amarin Investigational Site, Durban

4032

Amarin Investigational Site, Chermside

4037

Amarin Investigational Site, Newlands

4064

Amarin Investigational Site, Brisbane

4120

Amarin Investigational Site, Hastings

4342

Amarin Investigational Site, New Plymouth

5042

Amarin Investigational Site, Bedford Park

6000

Amarin Investigational Site, Perth

6009

Amarin Investigational Site, Nedlands

6027

Amarin Investigational Site, Joondalup

6150

Amarin Investigational Site, Murdoch

6160

Amarin Investigational Site, Fremantle

6850

Amarin Investigational Site, Worcester

7010

Amarin Investigational Site, Nelson

7130

Amarin Investigational Site, Somerset West

7250

Amarin Investigational Site, Launceston

7405

Amarin Investigational Site, Pinelands

7460

Amarin Investigational Site, Goodwood

7500

Amarin Investigational Site, Panorama

Amarin Investigational Site, Parow

7530

Amarin Investigational Site, Bellville

7550

Amarin Investigational Site, Durbanville

7570

Amarin Investigational Site, Kraaifontein

7646

Amarin Investigational Site, Paarl

7925

Amarin Investigational Site, Cape Town

8011

Amarin Investigational Site, Christchurch

9016

Amarin Investigational Site, Dunedin

9301

Amarin Investigational Site, Bloemfontein

10001

Amarin Investigational Site, New York

10016

Amarin Investigational Site, New York

11023

Amarin Investigational Site, Great Neck

11206

Amarin Investigational Site, Brooklyn

11758

Amarin Investigational Site, North Massapequa

11787

Amarin Investigational Site, Smithtown

12206

Amarin Investigational Site, Albany

13088

Amarin Investigational Site, Liverpool

13850

Amarin Investigational Site, Vestal

14224

Amarin Investigational Site, West Seneca

15009

Amarin Investigational Site, Beaver

16684

Amarin Investigational Site, Tipton

17074

Amarin Investigational Site, Newport

17740

Amarin Investigational Site, Jersey Shore

18009

Amarin Investigational Site, Cherkasy

18901

Amarin Investigational Site, Doylestown

18960

Amarin Investigational Site, Sellersville

19067

Amarin Investigational Site, Yardley

19104

Amarin Investigational Site, Philadelphia

19460

Amarin Investigational Site, Phoenixville

19610

Amarin Investigational Site, Wyomissing

19718

Amarin Investigational Site, Newark

19803

Amarin Investigational Site, Wilmington

20037

Amarin Investigational Site, Washington D.C.

20109

Amarin Investigational Site, Manassas

20912

Amarin Investigational Site, Takoma Park

21018

Amarin Investigational Site, Vinnytsia

21029

Amarin Investigational Site, Vinnytsia

21093

Amarin Investigational Site, Lutherville

21236

Amarin Investigational Site, Baltimore

22044

Amarin Investigational Site, Falls Church

23114

Amarin Investigational Site, Midlothian

23606

Amarin Investigational Site, Newport News

25701

Amarin Investigational Site, Huntington

27157

Amarin Investigational Site, Winston-Salem

27284

Amarin Investigational Site, Kernersville

27609

Amarin Investigational Site, Raleigh

27710

Amarin Investigational Site, Durham

28054

Amarin Investigational Site, Gastonia

28204

Amarin Investigational Site, Charlotte

29681

Amarin Investigational Site, Simpsonville

29720

Amarin Investigational Site, Lancaster

30014

Amarin Investigational Site, Covington

30041

Amarin Investigational Site, Cumming

30076

Amarin Investigational Site, Roswell

30094

Amarin Investigational Site, Conyers

32003

Amarin Investigational Site, Fleming Island

32132

Amarin Investigational Site, Edgewater

32204

Amarin Investigational Site, Jacksonville

32205

Amarin Investigational Site, Jacksonville

32207

Amarin Investigational Site, Jacksonville

32216

Amarin Investigational Site, Jacksonville

32803

Amarin Investigational Site, Orlando

32960

Amarin Investigational Site, Vero Beach

33014

Amarin Investigational Site, Miami Lakes

33026

Amarin Investigational Site, Pembroke Pines

33140

Amarin Investigational Site, Miami Beach

33144

Amarin Investigational Site, Miami

33175

Amarin Investigational Site, Miami

33308

Amarin Investigational Site, Fort Lauderdale

33312

Amarin Investigational Site, Fort Lauderdale

33324

Amarin Investigational Site, Plantation

33401

Amarin Investigational Site, West Palm Beach

33437

Amarin Investigational Site, Boynton Beach

33713

Amarin Investigational Site, St. Petersburg

33756

Amarin Investigational Site, Clearwater

34209

Amarin Investigational Site, Bradenton

34233

Amarin Investigational Site, Sarasota

34429

Amarin Investigational Site, Inverness

34471

Amarin Investigational Site, Ocala

34695

Amarin Investigational Site, Safety Harbor

35205

Amarin Investigational Site, Birmingham

35235

Amarin Investigational Site, Birmingham

35662

Amarin Investigational Site, Muscle Shoals

35801

Amarin Investigational Site, Huntsville

36011

Amarin Investigational Site, Poltava

36608

Amarin Investigational Site, Mobile

37167

Amarin Investigational Site, Smyrna

37620

Amarin Investigational Site, Bristol

37917

Amarin Investigational Site, Knoxville

38138

Amarin Investigational Site, Germantown

38301

Amarin Investigational Site, Jackson

38401

Amarin Investigational Site, Columbia

38801

Amarin Investigational Site, Tupelo

39531

Amarin Investigational Site, Biloxi

40213

Amarin Investigational Site, Louisville

43000

Amarin Investigational Site, Lutsk

43024

Amarin Investigational Site, Lutsk

44053

Amarin Investigational Site, Lorain

44870

Amarin Investigational Site, Sandusky

45219

Amarin Investigational Site, Cincinnati

45419

Amarin Investigational Site, Dayton

46003

Amarin Investigational Site, Ternopil

47713

Amarin Investigational Site, Evansville

48098

Amarin Investigational Site, Troy

48910

Amarin Investigational Site, Lansing

49006

Amarin Investigational Site, Dnipropetrovsk

49023

Amarin Investigational Site, Dnipropetrovsk

49027

Amarin Investigational Site, Dnipropetrovsk

49855

Amarin Investigational Site, Marquette

52242

Amarin Investigational Site, Iowa City

56303

Amarin Investigational Site, Saint Cloud

57701

Amarin Investigational Site, Rapid City

58002

Amarin Investigational Site, Chernivtsi

58103

Amarin Investigational Site, Fargo

60064

Amarin Investigational Site, North Chicago

60101

Amarin Investigational Site, Addison

60190

Amarin Investigational Site, Winfield

60611

Amarin Investigational Site, Chicago

61002

Amarin Investigational Site, Kharkiv

61018

Amarin Investigational Site, Kharkiv

61039

Amarin Investigational Site, Kharkiv

61176

Amarin Investigational Site, Kharkiv

61636

Amarin Investigational Site, Peoria

61761

Amarin Investigational Site, Norman

63031

Amarin Investigational Site, Florissant

63110

Amarin Investigational Site, St Louis

63141

Amarin Investigational Site, Chesterfield

63303

Amarin Investigational Site, City of Saint Peters

64114

Amarin Investigational Site, Kansas City

65009

Amarin Investigational Site, Odesa

65025

Amarin Investigational Site, Odesa

65082

Amarin Investigational Site, Odesa

65109

Amarin Investigational Site, Jefferson City

67203

Amarin Investigational Site, Wichita

67207

Amarin Investigational Site, Wichita

68114

Amarin Investigational Site, Omaha

68154

Amarin Investigational Site, Omaha

68901

Amarin Investigational Site, Hastings

69035

Amarin Investigational Site, Zaporizhzhia

69065

Amarin Investigational Site, Zaporizhzhia

69106

Amarin Investigational Site, Zaporizhzhia

69600

Amarin Investigational Site, Zaporizhzhia

70072

Amarin Investigational Site, Marrero

70535

Amarin Investigational Site, Eunice

71301

Amarin Investigational Site, Alexandria

72204

Amarin Investigational Site, Little Rock

74104

Amarin Investigational Site, Tulsa

75007

Amarin Investigational Site, Carrollton

75075

Amarin Investigational Site, Plano

75231

Amarin Investigational Site, Dallas

76005

Amarin Investigational Site, Ivano-Frankivsk

76018

Amarin Investigational Site, Ivano-Frankivsk

76054

Amarin Investigational Site, Hurst

77024

Amarin Investigational Site, Houston

77025

Amarin Investigational Site, Houston

77030

Amarin Investigational Site, Houston

77053

Amarin Investigational Site, Houston

77070

Amarin Investigational Site, Houston

77077

Amarin Investigational Site, Houston

77079

Amarin Investigational Site, Houston

77372

Amarin Investigational Site, Splendora

77375

Amarin Investigational Site, Tomball

77702

Amarin Investigational Site, Beaumont

78130

Amarin Investigational Site, New Braunfels

78228

Amarin Investigational Site, San Antonio

78238

Amarin Investigational Site, San Antonio

78756

Amarin Investigational Site, Austin

79034

Amarin Investigational Site, Lviv

80012

Amarin Investigational Site, Aurora

80401

Amarin Investigational Site, Golden

80909

Amarin Investigational Site, Colorado Springs

83001

Amarin Investigational Site, Donetsk

83045

Amarin Investigational Site, Donetsk

84088

Amarin Investigational Site, West Jordan

85206

Amarin Investigational Site, Mesa

85251

Amarin Investigational Site, Phoenix

85745

Amarin Investigational Site, Tucson

87102

Amarin Investigational Site, Albuquerque

88000

Amarin Investigational Site, Uzhhorod

88014

Amarin Investigational Site, Uzhhorod

89052

Amarin Investigational Site, Henderson

89101

Amarin Investigational Site, Las Vegas

90015

Amarin Investigational Site, Los Angeles

90017

Amarin Investigational Site, Los Angeles

90033

Amarin Investigational Site, Los Angeles

90211

Amarin Investigational Site, Beverly Hills

90502

Amarin Investigational Site, Torrance

90716

Amarin Investigational Site, Hawaiian Gardens

90723

Amarin Investigational Site, Paramount

91016

Amarin Investigational Site, Luhansk

91436

Amarin Investigational Site, Encino

91710

Amarin Investigational Site, Chino

91950

Amarin Investigational Site, National City

92020

Amarin Investigational Site, El Cajon

92123

Amarin Investigational Site, San Diego

92868

Amarin Investigational Site, Orange

93003

Amarin Investigational Site, Ventura

93534

Amarin Investigational Site, Lancaster

94520

Amarin Investigational Site, Concord

94598

Amarin Investigational Site, Walnut Creek

95628

Amarin Investigational Site, Fair Oaks

95648

Amarin Investigational Site, Lincoln

95661

Amarin Investigational Site, Roseville

96818

Amarin Investigational Site, Honolulu

97239

Amarin Investigational Site, Portland

97702

Amarin Investigational Site, Bend

98166

Amarin Investigational Site, Burien

98405

Amarin Investigational Site, Tacoma

109240

Amarin Investigational Site, Moscow

110025

Amarin Investigational Site, New Delhi

110060

Amarin Investigational Site, New Delhi

110084

Amarin Investigational Site, Argeş

111020

Amarin Investigational Site, Moscow

111539

Amarin Investigational Site, Moscow

115093

Amarin Investigational Site, Moscow

117292

Amarin Investigational Site, Moscow

117593

Amarin Investigational Site, Moscow

117630

Amarin Investigational Site, Moscow

117997

Amarin Investigational Site, Moscow

121374

Amarin Investigational Site, Moscow

121552

Amarin Investigational Site, Moscow

124489

Amarin Investigational Site, Moscow

150030

Amarin Investigational Site, Yaroslavl

150062

Amarin Investigational Site, Yaroslavl

163000

Amarin Investigational Site, Arkhangelsk

163001

Amarin Investigational Site, Arkhangelsk

163045

Amarin Investigational Site, Arkhangelsk

185000

Amarin Investigational Site, Petrozavodsk

187342

Amarin Investigational Site, Kirovsk, Leningradskaya Region

190000

Amarin Investigational Site, Saint Petersburg

190107

Amarin Investigational Site, Saint Petersburg

192283

Amarin Investigational Site, Saint Petersburg

194044

Amarin Investigational Site, Saint Petersburg

194156

Amarin Investigational Site, Saint Petersburg

194291

Amarin Investigational Site, Saint Petersburg

194354

Amarin Investigational Site, Saint Petersburg

196601

Amarin Investigational Site, Saint Petersburg

197022

Amarin Investigational Site, Saint Petersburg

197110

Amarin Investigational Site, Saint Petersburg

197227

Amarin Investigational Site, Saint Petersburg

197341

Amarin Investigational Site, Saint Petersburg

197706

Amarin Investigational Site, Sestroretsk, Saint-Petersburg

197729

Amarin Investigational Site, Saint Petersburg

198205

Amarin Investigational Site, Saint Petersburg

199106

Amarin Investigational Site, Saint Petersburg

200030

Amarin Investigational Site, Craiova, Dolj

300359

Amarin Investigational Site, Timișoara

350086

Amarin Investigational Site, Krasnodar

394018

Amarin Investigational Site, Voronezh

394065

Amarin Investigational Site, Voronezh

400001

Amarin Investigational Site, Volgograd

400006

Amarin Investigational Site, Cluj-Napoca

410002

Amarin Investigational Site, Saratov

410028

Amarin Investigational Site, Saratov

411004

Amarin Investigational Site, Pune

420012

Amarin Investigational Site, Kazan'

420097

Amarin Investigational Site, Kazan'

422005

Amarin Investigational Site, Nashik

422055

Amarin Investigational Site, Mumbai

430123

Amarin Investigational Site, Maramureş

500001

Amarin Investigational Site, Hyderabad

500003

Amarin Investigational Site, Secunderabad

500004

Amarin Investigational Site, Hyderabad

530013

Amarin Investigational Site, Visakhapatnam

540098

Amarin Investigational Site, Mureş

540136

Amarin Investigational Site, Târgu Mureş

550245

Amarin Investigational Site, Sibiu

560034

Amarin Investigational Site, Bangalore

560038

Amarin Investigational Site, Bangalore

560052

Amarin Investigational Site, Bangalore

570015

Amarin Investigational Site, Mysore

570020

Amarin Investigational Site, Mysore

600086

Amarin Investigational Site, Chennai

603126

Amarin Investigational Site, Nizhny Novgorod

620102

Amarin Investigational Site, Yekaterinburg

620109

Amarin Investigational Site, Yekaterinburg

630008

Amarin Investigational Site, Novosibirsk

630047

Amarin Investigational Site, Novosibirsk

630089

Amarin Investigational Site, Novosibirsk

634050

Amarin Investigational Site, Tomsk

641037

Amarin Investigational Site, Coimbatore

643012

Amarin Investigational Site, Tomsk

650000

Amarin Investigational Site, Kemerovo

650002

Amarin Investigational Site, Kemerovo

686016

Amarin Investigational Site, Kottayam

700661

Amarin Investigational Site, Iași

810249

Amarin Investigational Site, Brăila

900203

Amarin Investigational Site, Constanța

06437

Amarin Investigational Site, Guilford

06102

Amarin Investigational Site, Hartford

04210

Amarin Investigational Site, Auburn

02118

Amarin Investigational Site, Boston

02215

Amarin Investigational Site, Boston

02721

Amarin Investigational Site, Fall River

07712

Amarin Investigational Site, Ocean City

T5A 4L8

Amarin Investigational Site, Edmonton

V3K 3V9

Amarin Investigational Site, Coquitlam

V5Z 1M9

Amarin Investigational Site, Vancouver

V6Z1Y6

Amarin Investigational Site, Vancouver

L6Z 4N5

Amarin Investigational Site, Brampton

L9Y 1W3

Amarin Investigational Site, Collingwood

N0N 1G0

Amarin Investigational Site, Corunna

L3Y 5G8

Amarin Investigational Site, Newmarket

N7T 4X3

Amarin Investigational Site, Sarnia

N7G 1Y7

Amarin Investigational Site, Strathroy

H7T 2P5

Amarin Investigational Site, Laval

H1T 1C8

Amarin Investigational Site, Montreal

H3H 1A1

Amarin Investigational Site, Montreal

J6E 6J2

Amarin Investigational Site, Saint-Charles-Borromée

J1J 2E3

Amarin Investigational Site, Sherbrooke

G1V 4G5

Amarin Investigational Site, Québec

G1V 4M6

Amarin Investigational Site, Québec

7600 SZ

Amarin Investigational Site, Almelo

3813 TZ

Amarin Investigational Site, Amersfoort

1261 AN

Amarin Investigational Site, Blaricum

2906 ZC

Amarin Investigational Site, Capelle aan den IJssel

1782 GZ

Amarin Investigational Site, Den Helder

7416 SE

Amarin Investigational Site, Deventer

6716 RP

Amarin Investigational Site, Ede

5611 NV

Amarin Investigational Site, Eindhoven

7513 ER

Amarin Investigational Site, Enschede

4462 RA

Amarin Investigational Site, Goes

4204 AA

Amarin Investigational Site, Gorinchem

2803 HH

Amarin Investigational Site, Gouda

9728 NT

Amarin Investigational Site, Groningen

2035 RC

Amarin Investigational Site, Haarlem

3844 DG

Amarin Investigational Site, Harderwijk

8441 PW

Amarin Investigational Site, Heerenveen

6419 PC

Amarin Investigational Site, Heerlen

2134 TM

Amarin Investigational Site, Hoofddorp

8934 AD

Amarin Investigational Site, Leeuwarden

2353 GA

Amarin Investigational Site, Leiderdorp

6532 SZ

Amarin Investigational Site, Nijmegen

4708 AE

Amarin Investigational Site, Roosendaal

3021 HC

Amarin Investigational Site, Rotterdam

3045 PM

Amarin Investigational Site, Rotterdam

3083 AN

Amarin Investigational Site, Rotterdam

5223 GV

Amarin Investigational Site, s'Hertogenbosch

3118 JH

Amarin Investigational Site, Schiedam

8601 ZK

Amarin Investigational Site, Sneek

2597 AX

Amarin Investigational Site, The Hague

5022 GC

Amarin Investigational Site, Tilburg

5042 AD

Amarin Investigational Site, Tilburg

5406 PT

Amarin Investigational Site, Uden

5504 DB

Amarin Investigational Site, Veldhoven

2725 NA

Amarin Investigational Site, Zoetermeer

7207 AE

Amarin Investigational Site, Zutphen

0622

Amarin Investigational Site, Takapuna

Amarin Investigational Site, Takapuna Auckland

0110

Amarin Investigational Site, Whangarei

15-351

Amarin Investigational Site, Bialystok

15-875

Amarin Investigational Site, Bialystok

40-748

Amarin Investigational Site, Katowice

40-772

Amarin Investigational Site, Katowice

31-011

Amarin Investigational Site, Krakow

43-190

Amarin Investigational Site, Mikolów

96-100

Amarin Investigational Site, Skierniewice

33-100

Amarin Investigational Site, Tarnów

01-231

Amarin Investigational Site, Warsaw

04-628

Amarin Investigational Site, Warsaw

01-192

Amarin Investigational Site, Warszawska

50-088

Amarin Investigational Site, Wroclaw

50-315

Amarin Investigational Site, Wroclaw

95-100

Amarin Investigational Site, Zgierz

010628

Amarin Investigational Site, Bucharest

011234

Amarin Investigational Site, Bucharest

0200054

Amarin Investigational Site, Bucharest

050098

Amarin Investigational Site, Bucharest

050524

Amarin Investigational Site, Bucharest

061098

Amarin Investigational Site, Bucharest

0157

Amarin Investigational Site, Pretoria

01032

Amarin Investigational Site, Kyiv

01103

Amarin Investigational Site, Kyiv

01151

Amarin Investigational Site, Kyiv

01601

Amarin Investigational Site, Kyiv

02091

Amarin Investigational Site, Kyiv

02660

Amarin Investigational Site, Kyiv

03151

Amarin Investigational Site, Kyiv

04050

Amarin Investigational Site, Kyiv

04114

Amarin Investigational Site, Kyiv

Sponsors

Lead Sponsor

Amarin Pharma Inc.
All Listed Sponsors
lead

Amarin Pharma Inc.

INDUSTRY