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NCT01807923 · ClinicalTrials.gov registry record · Phase 3
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
NCT01807923 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 559 participants.
The verdict
NCT01807923, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
Interventions
- DRUG Placebo
- DRUG Ivacaftor
- DRUG Lumacaftor Plus Ivacaftor Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01807923
The ClinicalTrials.gov registry entry for NCT01807923 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 559 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 3 interventions - of which Placebo is the first listed.
NCT01807923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01807923 about?
NCT01807923 is a clinical study titled "A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation". The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
What is the current status of trial NCT01807923?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2013-05. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01807923?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG), Lumacaftor Plus Ivacaftor Combination (DRUG).
Who is sponsoring clinical trial NCT01807923?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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