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NCT01531673 · ClinicalTrials.gov registry record · Phase 2
Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT01531673: Completed Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01531673 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531673, a Phase 2 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.
Primary Outcome
An AE is defined as 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. Serious Adverse Event (SAE) is any AE that results in any of the following: death; life-threatening condition; inpatient hospitalization o
Interventions
- DRUG Ivacaftor
- DRUG VX-661
- DRUG Placebo matched to VX-661
- DRUG Placebo matched to ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01531673 record still lists
NCT01531673 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 4 interventions - of which Ivacaftor is the first listed.
NCT01531673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531673 about?
NCT01531673 is a clinical study titled "Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation". The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.
What is the current status of trial NCT01531673?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2012-02. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01531673?
The interventions under investigation include: Ivacaftor (DRUG), VX-661 (DRUG), Placebo matched to VX-661 (DRUG), Placebo matched to ivacaftor (DRUG).
Who is sponsoring clinical trial NCT01531673?
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 NCT01531673's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 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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