NCT02392234 - A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation | Biotech Hunter

Enrollment

248

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions

Cystic Fibrosis

Interventions

DRUG

VX-661/Ivacaftor

Fixed dose combination tablet, oral use

DRUG

Ivacaftor

Tablet, oral use

DRUG

Placebo matched to VX-661/ ivacaftor

Fixed dose combination tablet, oral use

DRUG

Placebo matched to Ivacaftor

Tablet, oral use

Trial Locations (93)

Unknown

Birmingham

Phoenix

Tucson

Long Beach

Oakland

Palo Alto

Sacramento

Aurora

Denver

Gainesville

Miami

Orlando

Pensacola

Tampa

Atlanta

Chicago

Park Ridge

Iowa City

Baltimore

Boston

Ann Arbor

Grand Rapids

Minneapolis

St Louis

Lebanon

New York

Syracuse

Valhalla

Chapel Hill

Akron

Cincinnati

Cleveland

Toledo

Portland

Philadelphia

Pittsburgh

Charleston

Sioux Falls

Memphis

Austin

Dallas

Tyler

Salt Lake City

Norfolk

Seattle

Spokane

Milwaukee

Adelaide

Melbourne

South Brisbane

Westmead

Ghent

Montreal

Québec

Toronto

Vancouver

Marseille

Montpellier

Rennes

Lille

Paris

Bron

Bordeaux

Munich

München

Hanover

Essen

Jena

Berlin

Haifa

Jerusalem

Petah Tikva

Ramat Gan

Ancona

Milan

Orbassano

Potenza

Roma

Verona

Amsterdam

Rotterdam

The Hague

Utrecht

Bern

Sankt Gallen

Zurich

Exeter

London

Manchester

Southampton

Liverpool

Glasgow

Leeds

All Listed Sponsors

lead

Vertex Pharmaceuticals Incorporated

INDUSTRY