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NCT03525444 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT03525444: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03525444 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525444, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Interventions
- DRUG Placebo
- DRUG IVA
- DRUG VX-445/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 3 |
What the finished NCT03525444 record still lists
NCT03525444 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03525444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03525444 about?
NCT03525444 is a clinical study titled "A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)". This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
What is the current status of trial NCT03525444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2018-06-15. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT03525444?
The interventions under investigation include: Placebo (DRUG), IVA (DRUG), VX-445/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT03525444?
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 NCT03525444's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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