A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol

PHASE3CompletedINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

December 29, 2015

Study Completion Date

December 29, 2015

Conditions
HypercholesterolemiaHeterozygous Familial
Interventions
DRUG

mipomersen sodium 200 mg

Subcutaneous mipomersen 200 mg once weekly

DRUG

Placebo

Placebo vehicle for subcutaneous injection.

DRUG

mipomersen sodium 70 mg

Subcutaneous mipomersen 70 mg thrice weekly

Trial Locations (113)

Unknown

Mission Viejo

Aurora

Cooper City

Winter Park

Indianapolis

Kansas City

Boston

Ann Arbor

Grandville

Rochester

St Louis

Omaha

Summit

North Massapequa

Portland

Lancaster

Charleston

Nashville

Dallas

Norfolk

Buenos Aires

Córdoba

Perth

South Brisbane

Edegem

Haine-Saint-Paul

Leuven

Rio de Janeiro

São Paulo

Chicoutimi

Montreal

Sainte-Foy

Osijek

Zagreb

Hradec Králové

Prague

Aarhus

Viborg

Aachen

Berlin

Cologne

Freiburg im Breisgau

Hamburg

Heidelberg

Magdeburg

Ioannina

Kallithea

Hong Kong

Baja

Budapest

Debrecen

New Delhi

Holon

Kfar Saba

Ofakim

Bologna

Napoli

Padua

Palermo

Pisa

Roma

Kuala Lumpur

Kubang Kerian

Alkmaar

Amsterdam

Maastricht

Nijmegen

Utrecht

Waalwijk

Christchurch

Bodø

Oslo

Sandefjord

Bialystok

Gdansk

Katowice

Krakow

Nałęczów

Poznan

Sopot

Szczecin

Warsaw

Wroclaw

Barnaul

Kemerovo

Moscow

Novosibirsk

Petrozavodsk

Ryazan

Saint Petersburg

Tomsk

Yaroslavl

Cape Town

Pretoria

Seoul

Madrid

Stockholm

New Taipei City

Taipei

Ankara

Istanbul

Izmir

Sivas

Ivano-Frankivsk

Kiev

Kyiv

Odesa

Birmingham

Cardiff

Liverpool

London

Manchester

Oldham

Sponsors
All Listed Sponsors
lead

Kastle Therapeutics, LLC

INDUSTRY

NCT01475825 - A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol | Biotech Hunter | Biotech Hunter