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NCT03525574 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
507
Enrollment target

NCT03525574: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

NCT03525574 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03525574, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
507 participants
Enrollment target

Study Summary

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

Interventions

  • DRUG IVA
  • DRUG ELX/TEZ/IVA

Trial Details

FieldValue
Enrollment Target 507 participants
Start Date 2018-10-09
Est. Completion 2023-01-09
Phase Phase 3
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT03525574 record still lists

NCT03525574 is an interventional study that assigns participants to a tested intervention. The registered 507 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 (34% lower).

The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.

NCT03525574 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03525574 about?

NCT03525574 is a clinical study titled "A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy". The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

What is the current status of trial NCT03525574?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2018-10-09. Estimated completion is 2023-01-09.

What interventions are being tested in trial NCT03525574?

The interventions under investigation include: IVA (DRUG), ELX/TEZ/IVA (DRUG).

Who is sponsoring clinical trial NCT03525574?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03525574's enrollment target sits among peer trials

507 739th of 2000 higher than 1,260 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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Source: ClinicalTrials.gov NCT03525574, the US trial registry maintained by the National Library of Medicine. NCT03525574 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.