Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

May 31, 2010

Study Completion Date

October 31, 2010

Conditions
HypercholesterolemiaCoronary Heart Disease
Interventions
DRUG

Mipomersen sodium

200 mg/mL

DRUG

Placebo

1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).

Trial Locations (62)

13790

Johnson City

19446

Lansdale

21209

Baltimore

27834

Greenville

27893

Wilson

28204

Charlotte

29303

Spartanburg

29576

Murrells Inlet

29681

Simpsonville

30328

Sandy Springs

32081

Ponte Verda

32127

Port Orange

32216

Jacksonville

32514

Pensacola

32779

Longwood

33026

Pembroke Pines

33143

Miami

33169

Miami

33180

Aventura

34452

Inverness

34652

New Port Richey

35209

Birmingham

35294

Birmingham

35662

Muscle Shoals

35801

Huntsville

40213

Louisville

44060

Mentor

45219

Cincinnati

46254

Indianapolis

46260

Indianapolis

47403

Bloomingtom

47714

Evansville

55435

Edina

57702

Rapid City

60607

Chicago

60624

Chicago

60654

Chicago

64111

Kansas City

73069

Norman

74136

Tulsa

75220

Dallas

75251

Dallas

76051

Grapevine

77030

Houston

77074

Houston

77093

Houston

78229

San Antonio

85340

Litchfield Park

90025

Los Angeles

90211

Beverly Hills

91360

Thousand Oaks

91361

Westlake Village

92025

Escondido

92117

San Diego

92660

Newport Beach

92691

Mission Viejo

95405

Santa Rosa

97239

Portland

98502

Olympia

02301

Brockton

02740

New Bedford

08009

Berlin

Sponsors
All Listed Sponsors
collaborator

Ionis Pharmaceuticals, Inc.

INDUSTRY

lead

Kastle Therapeutics, LLC

INDUSTRY

NCT00770146 - Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients | Biotech Hunter | Biotech Hunter