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NCT02514473 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
206
Enrollment target

NCT02514473 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 206 participants.

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The verdict

NCT02514473, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
206 participants
Enrollment target

Study Summary

To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Interventions

  • DRUG Placebo
  • DRUG VX-809
  • DRUG VX-770

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2015-07
Est. Completion 2016-09
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT02514473

The ClinicalTrials.gov registry entry for NCT02514473 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 206 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.

NCT02514473 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02514473 about?

NCT02514473 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation". To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

What is the current status of trial NCT02514473?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2015-07. Estimated completion is 2016-09.

What interventions are being tested in trial NCT02514473?

The interventions under investigation include: Placebo (DRUG), VX-809 (DRUG), VX-770 (DRUG).

Who is sponsoring clinical trial NCT02514473?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.