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
Public ClinicalTrials.gov record NCT01807923. 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.
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, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01807923
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 559 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- 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
- Apr 30, 2013
- Primary completion
- Mar 31, 2014
- Completion
- Mar 31, 2014
- Last update posted
- Aug 30, 2015
2013 – 2014
United States locations
- U.S. sites
- 48
- U.S. states
- 28
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Anchorage | Alaska | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Fresno | California | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Loma Linda | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Madera | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Gainsville | Florida | — | — |
| Not listed | Hollywood | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Park Ridge | Illinois | — | — |
| Not listed | Peoria | Illinois | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Bedford | New Hampshire | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Long Branch | New Jersey | — | — |
| Not listed | Hawthorne | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Valhalla | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Dayton | Ohio | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Knoxville | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Tyler | Texas | — | — |
| Not listed | Colchester | Vermont | — | — |
| Not listed | Charlottesville | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Morgantown | West Virginia | — | — |
| Not listed | Madison | 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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01807923, 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 Aug 30, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01807923 live on ClinicalTrials.gov.