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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: Completed Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospita
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 |
What the finished NCT01225211 record still lists
NCT01225211 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (76% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01225211's enrollment target sits among peer trials
312 21st of 169 higher than 149 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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