A 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
Public ClinicalTrials.gov record NCT02516410. 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, 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 With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).
Study identification
- NCT ID
- NCT02516410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Interventions
- VX-661 plus ivacaftor combination Drug
- Ivacaftor Drug
- Placebo (matched to VX-661 plus ivacaftor combination) 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
- Aug 2015 (Type not available)
- Primary completion
- Jun 7, 2016 (Actual)
- Completion
- Jun 7, 2016 (Actual)
- Last update posted
- Jun 12, 2018
2015 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 18
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Spokane | Washington | — | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02516410, 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 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02516410 live on ClinicalTrials.gov.