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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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 510 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02347657
The ClinicalTrials.gov registry entry for NCT02347657 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02347657 reports 0 study locations.
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.
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