# A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

> **NCT01931839** · PHASE3 · COMPLETED · sponsor: **Vertex Pharmaceuticals Incorporated** · enrollment: 1164 (actual)

## Conditions studied

- Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

## Interventions

- **DRUG:** Lumacaftor Plus Ivacaftor Combination
- **DRUG:** Ivacaftor

## Key facts

- **NCT ID:** NCT01931839
- **Lead sponsor:** Vertex Pharmaceuticals Incorporated
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-10
- **Primary completion:** 2016-04
- **Final completion:** 2016-04
- **Target enrollment:** 1164 (ACTUAL)
- **Last updated:** 2017-05-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01931839

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01931839, "A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis". Retrieved via AI Analytics 2026-09-26 from https://api.ai-analytics.org/clinical/NCT01931839. Licensed CC0.

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