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NCT00457821 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
A Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00457821 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 39 participants.
The verdict
NCT00457821, a Phase 2 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a 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 25 mg/75 mg
- DRUG Ivacaftor 75 mg/150 mg
- DRUG Ivacaftor 150 mg or 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00457821
The ClinicalTrials.gov registry entry for NCT00457821 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 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 4 interventions - of which Placebo is the first listed.
NCT00457821 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00457821 about?
NCT00457821 is a clinical study titled "Safety Study of Ivacaftor in Subjects With Cystic Fibrosis". The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentia...
What is the current status of trial NCT00457821?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2007-05. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00457821?
The interventions under investigation include: Placebo (DRUG), Ivacaftor 25 mg/75 mg (DRUG), Ivacaftor 75 mg/150 mg (DRUG), Ivacaftor 150 mg or 250 mg (DRUG).
Who is sponsoring clinical trial NCT00457821?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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