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NCT02347657 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
510
Enrollment target

NCT02347657 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 510 participants.

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The verdict

NCT02347657, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
510 participants
Enrollment target

Study Summary

This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

Interventions

  • DRUG Ivacaftor
  • DRUG VX-661 Plus Ivacaftor Combination
  • DRUG VX-661 Plus Ivacaftor Combination Placebo
  • DRUG Ivacaftor placebo

Trial Details

FieldValue
Enrollment Target 510 participants
Start Date 2015-01
Est. Completion 2017-01-20
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT02347657

The ClinicalTrials.gov registry entry for NCT02347657 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 510 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.

NCT02347657 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02347657 about?

NCT02347657 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor". This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

What is the current status of trial NCT02347657?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2015-01. Estimated completion is 2017-01-20.

What interventions are being tested in trial NCT02347657?

The interventions under investigation include: Ivacaftor (DRUG), VX-661 Plus Ivacaftor Combination (DRUG), VX-661 Plus Ivacaftor Combination Placebo (DRUG), Ivacaftor placebo (DRUG).

Who is sponsoring clinical trial NCT02347657?

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.