# A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation

> **NCT02516410** · PHASE3 · COMPLETED · sponsor: **Vertex Pharmaceuticals Incorporated** · enrollment: 168 (actual)

## Conditions studied

- Cystic Fibrosis

## Interventions

- **DRUG:** VX-661 plus ivacaftor combination
- **DRUG:** Ivacaftor
- **DRUG:** Placebo (matched to VX-661 plus ivacaftor combination)
- **DRUG:** Placebo (matched to ivacaftor)

## Key facts

- **NCT ID:** NCT02516410
- **Lead sponsor:** Vertex Pharmaceuticals Incorporated
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-08
- **Primary completion:** 2016-06-07
- **Final completion:** 2016-06-07
- **Target enrollment:** 168 (ACTUAL)
- **Last updated:** 2018-06-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02516410

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02516410, "A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT02516410. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*