A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

PHASE3CompletedINTERVENTIONAL
Enrollment

563

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

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

Placebo

Matching placebo tablet

DRUG

Lumacaftor Plus Ivacaftor Combination

Fixed dose combination tablet

DRUG

Ivacaftor

Film-coated tablet

Trial Locations (82)

Unknown

Oakland

Sacramento

Aurora

Hartford

New Haven

Jacksonville

Miami

Indianapolis

Iowa City

Kansas City

Lexington

Portland

Worcester

Detroit

Grand Rapids

Minneapolis

Jackson

St Louis

Omaha

Morristown

New Brunswick

Albuquerque

Albany

Buffalo

New York

Rochester

Syracuse

Cleveland

Columbus

Toledo

Oklahoma City

Philadelphia

Pittsburgh

Charleston

Sioux Falls

Memphis

Nashville

Dallas

Fort Worth

Houston

San Antonio

Salt Lake City

Richmond

Seattle

Spokane

Milwaukee

Brisbane

Chermside

Herston

South Brisbane

Nedlands

Subiaco

Innsbruck

Wels

Brussels

Ghent

Leuven

Liège

Calgary

Edmonton

Vancouver

Montreal

København Ø

Marseille

Toulouse

Montpellier

Lille

Paris

Bordeaux

Munich

Frankfurt am Main

Giessen

Hanover

Bochum

Jena

Barcelona

Valencia

Bristol

London

Liverpool

Newcastle upon Tyne

Leeds

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT01807949 - A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | Biotech Hunter | Biotech Hunter