A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
Public ClinicalTrials.gov record NCT02412111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.
Study identification
- NCT ID
- NCT02412111
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 156 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2015
- Primary completion
- Aug 31, 2017
- Completion
- Aug 31, 2017
- Last update posted
- Jan 7, 2019
2015 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 24
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Augusta | Georgia | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Grand Rapids | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Manchester | New Hampshire | — | — |
| Not listed | Morristown | New Jersey | — | — |
| Not listed | New Brunswick | New Jersey | — | — |
| Not listed | Albany | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Knoxville | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02412111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2019 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02412111 live on ClinicalTrials.gov.