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NCT01807949 · 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 of Cystic Fibrosis, Homozygous for the F508del CFTR Mutation, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 563
- Enrollment target
- 20
- Study locations
NCT01807949 is a Phase 3 study of Cystic Fibrosis, Homozygous for the F508del CFTR Mutation that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 563 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT01807949, a Phase 3 study of Cystic Fibrosis, Homozygous for the F508del CFTR Mutation, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 563 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ivacaftor
- DRUG Lumacaftor Plus Ivacaftor Combination
Study Locations (20)
California
- - Oakland
- - Sacramento
Connecticut
- - Hartford
- - New Haven
Florida
- - Jacksonville
- - Miami
Michigan
- - Detroit
- - Grand Rapids
Colorado
- - Aurora
Indiana
- - Indianapolis
Iowa
- - Iowa City
Kansas
- - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01807949
The ClinicalTrials.gov registry entry for NCT01807949 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 563 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 1 condition, with Cystic Fibrosis, Homozygous for the F508del CFTR Mutation appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01807949 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT01807949 about?
NCT01807949 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 NCT01807949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 563 participants. The study started on 2013-04. Estimated completion is 2014-04.
What conditions does trial NCT01807949 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation.
What interventions are being tested in trial NCT01807949?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG), Lumacaftor Plus Ivacaftor Combination (DRUG).
Who is sponsoring clinical trial NCT01807949?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01807949 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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