# A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

> **NCT02392234** · PHASE3 · COMPLETED · sponsor: **Vertex Pharmaceuticals Incorporated** · enrollment: 248 (actual)

## Conditions studied

- Cystic Fibrosis

## Interventions

- **DRUG:** VX-661/Ivacaftor
- **DRUG:** Ivacaftor
- **DRUG:** Placebo matched to VX-661/ ivacaftor
- **DRUG:** Placebo matched to Ivacaftor

## Key facts

- **NCT ID:** NCT02392234
- **Lead sponsor:** Vertex Pharmaceuticals Incorporated
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-03
- **Primary completion:** 2017-02
- **Final completion:** 2017-02
- **Target enrollment:** 248 (ACTUAL)
- **Last updated:** 2018-06-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02392234

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02392234, "A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT02392234. Licensed CC0.

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