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NCT00909532 · ClinicalTrials.gov registry record · Phase 3
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
NCT00909532 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 167 participants.
The verdict
NCT00909532, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00909532
The ClinicalTrials.gov registry entry for NCT00909532 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 167 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 2 interventions - of which Placebo is the first listed.
NCT00909532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00909532 about?
NCT00909532 is a clinical study titled "Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation". 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-typ...
What is the current status of trial NCT00909532?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2009-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00909532?
The interventions under investigation include: Placebo (DRUG), Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT00909532?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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