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NCT01225211 · ClinicalTrials.gov registry record · Phase 2
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
A Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
- 20
- Study locations
NCT01225211 is a Phase 2 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 312 participants, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT01225211, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
Conditions Studied
Interventions
- DRUG Ivacaftor
- DRUG Lumacaftor
- DRUG Lumacaftor Placebo
- DRUG Ivacaftor Placebo
Study Locations (20)
California
- - La Jolla
- - Long Beach
- - Palo Alto
- - Sacramento
Florida
- - Miami
- - Orlando
- - Tampa
Alabama
- - Birmingham
Alaska
- - Anchorage
Colorado
- - Denver
Connecticut
- - New Haven
Georgia
- - Atlanta
Idaho
- - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01225211
The ClinicalTrials.gov registry entry for NCT01225211 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (76% higher). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 4 interventions - of which Ivacaftor is the first listed.
NCT01225211 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01225211 about?
NCT01225211 is a clinical study titled "Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation". The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
What is the current status of trial NCT01225211?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2010-10. Estimated completion is 2014-04.
What conditions does trial NCT01225211 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01225211?
The interventions under investigation include: Ivacaftor (DRUG), Lumacaftor (DRUG), Lumacaftor Placebo (DRUG), Ivacaftor Placebo (DRUG).
Who is sponsoring clinical trial NCT01225211?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01225211 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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