Clinical trial
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
NCT00457821 · Vertex Pharmaceuticals Incorporated, Industry · Completed
Key facts
| NCT number | NCT00457821 |
|---|---|
| Title | Safety Study of Ivacaftor in Subjects With Cystic Fibrosis |
| Official title | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D |
| Lead sponsor | Vertex Pharmaceuticals Incorporated, Industry |
| Collaborators | Cystic Fibrosis Foundation |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Cystic Fibrosis |
| Intervention type | Drug |
| Interventions | Ivacaftor 25 mg/75 mg, Ivacaftor 75 mg/150 mg, Ivacaftor 150 mg or 250 mg, Placebo |
| Enrollment | 39 |
| Start date | May 1, 2007 |
| Primary completion | Aug 1, 2008 |
| Completion | Aug 1, 2008 |
| First posted | Apr 9, 2007 |
| Last update posted | Oct 5, 2012 |
| Countries | Canada, Germany, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: