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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 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 194 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01531673
The ClinicalTrials.gov registry entry for NCT01531673 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 194 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.
NCT01531673 reports 0 study locations.
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.
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