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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02514473

Public ClinicalTrials.gov record NCT02514473. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 10:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02514473
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
206 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2015 (Type not available)
Primary completion
Sep 2016 (Actual)
Completion
Sep 2016 (Actual)
Last update posted
Oct 23, 2017

2015 – 2016

United States locations

U.S. sites
29
U.S. states
22
U.S. cities
29
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Not listed Los Angeles California — —
Not listed Palo Alto California — —
Not listed Aurora Colorado — —
Not listed Wilmington Delaware — —
Not listed Orlando Florida — —
Not listed Atlanta Georgia — —
Not listed Chicago Illinois — —
Not listed Iowa City Iowa — —
Not listed Boston Massachusetts — —
Not listed Minneapolis Minnesota — —
Not listed Kansas City Missouri — —
Not listed Omaha Nebraska — —
Not listed Manchester New Hampshire — —
Not listed Chapel Hill North Carolina — —
Not listed Cincinnati Ohio — —
Not listed Cleveland Ohio — —
Not listed Dayton Ohio — —
Not listed Philadelphia Pennsylvania — —
Not listed Pittsburgh Pennsylvania — —
Not listed Charleston South Carolina — —
Not listed Salt Lake City Utah — —
Not listed Colchester Vermont — —
Not listed Charlottesville Virginia — —
Not listed Norfolk Virginia — —
Not listed Richmond Virginia — —
Not listed Seattle Washington — —
Not listed Madison Wisconsin — —
Not listed Milwaukee Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02514473, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 23, 2017 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02514473 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →