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NCT02070744 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02070744: Completed Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02070744 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02070744, a Phase 2 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation
Primary Outcome
AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death,
Interventions
- DRUG Ivacaftor
- DRUG Placebo matched to Ivacaftor
- DRUG VX-661
- DRUG Placebo matched to VX-661
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-05-27 |
| Phase | Phase 2 |
What the finished NCT02070744 record still lists
NCT02070744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02070744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02070744 about?
NCT02070744 is a clinical study titled "Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion". The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation
What is the current status of trial NCT02070744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2014-03. Estimated completion is 2016-05-27.
What interventions are being tested in trial NCT02070744?
The interventions under investigation include: Ivacaftor (DRUG), Placebo matched to Ivacaftor (DRUG), VX-661 (DRUG), Placebo matched to VX-661 (DRUG).
Who is sponsoring clinical trial NCT02070744?
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 NCT02070744's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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