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A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

NCT01807923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2015-08-31

Study results available
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Summary

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Conditions

  • Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Interventions

DRUG

Lumacaftor Plus Ivacaftor Combination

Fixed dose combination tablet

DRUG

Ivacaftor

Film-coated tablet

DRUG

Placebo

Matching placebo tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01807923 on ClinicalTrials.gov