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NCT02516410 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
NCT02516410: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02516410 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02516410, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
Study Summary
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 \[NR\]).
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.
Interventions
- DRUG Ivacaftor
- DRUG VX-661 plus ivacaftor combination
- DRUG Placebo (matched to VX-661 plus ivacaftor combination)
- DRUG Placebo (matched to ivacaftor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-06-07 |
| Phase | Phase 3 |
What the finished NCT02516410 record still lists
NCT02516410 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02516410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02516410 about?
NCT02516410 is a clinical study titled "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". 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...
What is the current status of trial NCT02516410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2015-08. Estimated completion is 2016-06-07.
What interventions are being tested in trial NCT02516410?
The interventions under investigation include: Ivacaftor (DRUG), VX-661 plus ivacaftor combination (DRUG), Placebo (matched to VX-661 plus ivacaftor combination) (DRUG), Placebo (matched to ivacaftor) (DRUG).
Who is sponsoring clinical trial NCT02516410?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02516410's enrollment target sits among peer trials
168 1459th of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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