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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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 168 participants.
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 \[NR\]).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02516410
The ClinicalTrials.gov registry entry for NCT02516410 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 168 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.
NCT02516410 reports 0 study locations.
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.
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