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

559

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

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

Lumacaftor Plus Ivacaftor Combination

Fixed dose combination tablet

DRUG

Ivacaftor

Film-coated tablet

DRUG

Placebo

Matching placebo tablet

Trial Locations (89)

Unknown

Birmingham

Anchorage

Tucson

Little Rock

Fresno

La Jolla

Loma Linda

Long Beach

Los Angeles

Madera

Oakland

Palo Alto

Denver

Gainsville

Hollywood

Orlando

Tampa

Atlanta

Boise

Chicago

Park Ridge

Peoria

Baltimore

Boston

Ann Arbor

Kansas City

Bedford

Lebanon

Long Branch

Hawthorne

New York

Valhalla

Chapel Hill

Durham

Akron

Cincinnati

Dayton

Portland

Hershey

Knoxville

Austin

Tyler

Colchester

Charlottesville

Norfolk

Seattle

Morgantown

Madison

Broadmeadow

Westmead

Adelaide

Halifax

Vancouver

Ottawa

Toronto

Brno

Plzen-Bory

Prague

Strasbourg

Roscoff

Paris

Bron

Pierre-Bénite

Tübingen

Erlangen

Würzburg

Cologne

Leipzig

Berlin

Dublin

Tallaght

Florence

Ancona

Genova

Milan

Roma

Verona

Amsterdam

Nijmegen

Rotterdam

The Hague

Gothenburg

Stockholm

Uppsala

Belfast

Exeter

Southhampton

Nottingham

Birmingham

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT01807923 - 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