A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,164

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Interventions
DRUG

Lumacaftor Plus Ivacaftor Combination

Fixed dose combination tablet, oral use

DRUG

Ivacaftor

Film-coated tablet, oral use

Trial Locations (166)

Unknown

Birmingham

Anchorage

Tucson

Little Rock

La Jolla

Loma Linda

Longbeach

Los Angeles

Madera

Oakland

Palo Alto

Sacramento

Aurora

Denver

Hartford

New Haven

Altamonte Springs

Hollywood

Jacksonville

Miami

Orlando

Tampa

Atlanta

Boise

Chicago

Park Ridge

Peoria

Indianapolis

Iowa City

Kansas City

Lexington

New Orleans

South Portland

Baltimore

Boston

Worcester

Ann Arbor

Detroit

Grand Rapids

Minneapolis

Jackson

Kansas City

St Louis

Omaha

Bedford

Lebanon

Long Branch

Morristown

New Brunswick

Albuquerque

Albany

Buffalo

Lake Success

New York

Rochester

Syracuse

Valhalla

Chapel Hill

Durham

Akron

Cincinnati

Cleveland

Columbus

Dayton

Toledo

Oklahoma City

Portland

Hershey

Philadelphia

Pittsburgh

Charelston

Sioux Falls

Knoxville

Memphis

Nashville

Austin

Dallas

Fort Worth

Houston

San Antonio

Tyler

Salt Lake City

Colchester

Charlottesville

Norfolk

Richmond

Seattle

Spokane

Morgantown

Madison

Milwaukee

New Lambton Heights

Westmead

Adelaide

Chermside

Herston

South Brisbane

Nedlands

Subiaco

Innsbruck

Wels

Brussels

Ghent

Leuven

Liège

Calgary

Edmonton

Vancouver

Halifax

Ottowa

Toronto

Montreal

Brno

Plzeň - Bory

Prague

Copenhagen

Strasbourg

Marseille

Toulouse

Montpellier

Lille

Bron

Bordeaux

Paris

Pierre-Bénite

Rhone

Roscoff

Munich

München

München

Berlin

Bochum

Cologne

Erlangen

Essen

Frankfurt

Giessen

Hanover

Jena

Leipzig

Tübingen

Würzburg

Dublin

Ancona

Florence

Genova

Milan

Roma

Verona

Amsterdam

Nijmegen

Rotterdam

The Hague

Barcelona

Valencia

Gothenburg

Stockholm

Exeter

Belfast

Birmingham

Bristol

Leeds

London

Newcastle

Nottingham

Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT01931839 - A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis | Biotech Hunter | Biotech Hunter