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NCT02392234 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
248
Enrollment target
20
Study locations

NCT02392234 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 248 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT02392234, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
248 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

Conditions Studied

Cystic Fibrosis

Interventions

  • DRUG Ivacaftor
  • DRUG VX-661/Ivacaftor
  • DRUG Placebo matched to VX-661/ ivacaftor
  • DRUG Placebo matched to Ivacaftor

Study Locations (20)

Florida

  • - Gainesville
  • - Miami
  • - Orlando
  • - Pensacola
  • - Tampa

California

  • - Long Beach
  • - Oakland
  • - Palo Alto
  • - Sacramento

Arizona

  • - Phoenix
  • - Tucson

Colorado

  • - Aurora
  • - Denver

Illinois

  • - Chicago
  • - Park Ridge

Alabama

  • - Birmingham

Georgia

  • - Atlanta

Iowa

  • - Iowa City

Trial Details

FieldValue
Enrollment Target 248 participants
Start Date 2015-03
Est. Completion 2017-02
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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What the Registry Record Tells You About NCT02392234

The ClinicalTrials.gov registry entry for NCT02392234 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (39% higher). 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 appearing as the primary indexed condition, and to 4 interventions - of which Ivacaftor is the first listed.

NCT02392234 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT02392234 about?

NCT02392234 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation". The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual functi...

What is the current status of trial NCT02392234?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2015-03. Estimated completion is 2017-02.

What conditions does trial NCT02392234 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT02392234?

The interventions under investigation include: Ivacaftor (DRUG), VX-661/Ivacaftor (DRUG), Placebo matched to VX-661/ ivacaftor (DRUG), Placebo matched to Ivacaftor (DRUG).

Who is sponsoring clinical trial NCT02392234?

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

Where is trial NCT02392234 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.