A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
NCT02347657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510
Last updated 2018-06-12
Summary
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
Conditions
Interventions
- DRUG
-
VX-661 Plus Ivacaftor Combination
FDC tablet, oral use
- DRUG
-
Ivacaftor
Tablet, oral use
- DRUG
-
VX-661 Plus Ivacaftor Combination Placebo
FDC tablet, oral use
- DRUG
-
Ivacaftor placebo
Tablet, oral use
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2017-01-20
- Completion
- 2017-01-20
Countries
- United States
- Canada
- Denmark
- France
- Germany
- Ireland
- Italy
- Netherlands
- Spain
- Sweden
- Switzerland
- United Kingdom
Study Locations
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