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NCT02347657 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
NCT02347657: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02347657 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347657, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
Study 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.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Interventions
- DRUG Ivacaftor
- DRUG VX-661 Plus Ivacaftor Combination
- DRUG VX-661 Plus Ivacaftor Combination Placebo
- DRUG Ivacaftor placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 3 |
What the finished NCT02347657 record still lists
NCT02347657 is an interventional study that assigns participants to a tested intervention. The registered 510 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 (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02347657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02347657 about?
NCT02347657 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor". 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.
What is the current status of trial NCT02347657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2015-01. Estimated completion is 2017-01-20.
What interventions are being tested in trial NCT02347657?
The interventions under investigation include: Ivacaftor (DRUG), VX-661 Plus Ivacaftor Combination (DRUG), VX-661 Plus Ivacaftor Combination Placebo (DRUG), Ivacaftor placebo (DRUG).
Who is sponsoring clinical trial NCT02347657?
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 NCT02347657's enrollment target sits among peer trials
510 729th of 2000 higher than 1,264 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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