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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: Completed Phase 2 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT00457821 is a Phase 2 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.
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 |
What the finished NCT00457821 record still lists
NCT00457821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00457821 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00457821's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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