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
Public ClinicalTrials.gov record NCT02392234. 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, Placebo-Controlled, Crossover 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-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.
Study identification
- NCT ID
- NCT02392234
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Interventions
- VX-661/Ivacaftor Drug
- Ivacaftor Drug
- Placebo matched to VX-661/ ivacaftor Drug
- Placebo matched to Ivacaftor Drug
Drug
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
- Mar 2015 (Type not available)
- Primary completion
- Feb 2017 (Actual)
- Completion
- Feb 2017 (Actual)
- Last update posted
- Jun 12, 2018
2015 – 2017
United States locations
- U.S. sites
- 47
- U.S. states
- 27
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Pensacola | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Park Ridge | Illinois | — | — |
| Not listed | Iowa City | Iowa | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Grand Rapids | Michigan | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Valhalla | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Tyler | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Spokane | Washington | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02392234, 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 Jun 12, 2018 · Synced Oct 23, 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 public registry record, listed eligibility criteria, and available contact information for NCT02392234 live on ClinicalTrials.gov.