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NCT01117012 · ClinicalTrials.gov registry record · Phase 3
Rollover Study of VX-770 in Cystic Fibrosis Subjects
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 192
- Enrollment target
NCT01117012: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01117012 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 192 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01117012, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 192 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
Primary Outcome
Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death,
Interventions
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01117012 record still lists
NCT01117012 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Ivacaftor is the first listed.
NCT01117012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01117012 about?
NCT01117012 is a clinical study titled "Rollover Study of VX-770 in Cystic Fibrosis Subjects". The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
What is the current status of trial NCT01117012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2010-07. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01117012?
The interventions under investigation include: Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT01117012?
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 NCT01117012's enrollment target sits among peer trials
192 1398th of 2000 higher than 599 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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