Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
Public ClinicalTrials.gov record NCT00909532. 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 VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
Study identification
- NCT ID
- NCT00909532
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 167 participants
Conditions and interventions
Conditions
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
- Jun 2009 (Type not available)
- Primary completion
- Jul 2010 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Jan 18, 2013
2009 – 2012
United States locations
- U.S. sites
- 39
- U.S. states
- 26
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233-1711 | — |
| Kaiser Permanente Medical Care Program | Oakland | California | 94611 | — |
| Cystic Fibrosis Research Office, Stanford University | Palo Alto | California | 94304 | — |
| Rady Children's Hospital | San Diego | California | 92123-5070 | — |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | — |
| Emory Cystic Fibrosis Center | Atlanta | Georgia | 30322 | — |
| St. Luke's CF Clinic | Boise | Idaho | 83712 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Pulmonary, Allergy & Critical Care Medicine, University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Adult Pulmonary/ CF, University of Nebraska Medical Center | Omaha | Nebraska | 68198-5300 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Pediatric & Pulmonary Division, Rainbow Babies/Case Western | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Oregon Health & Sciences University | Portland | Oregon | 97239-3098 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-5735 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Division of Pulmonary and CCM, University of Washington | Seattle | Washington | 98195-6522 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00909532, 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 Jan 18, 2013 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00909532 live on ClinicalTrials.gov.