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Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation

NCT00909532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2013-01-18

Study results available
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Summary

The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

Conditions

Interventions

DRUG

Ivacaftor

150-mg tablets given orally q12h for up to 48 weeks

DRUG

Placebo

Tablet given orally q12h for up to 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bonnie W. Ramsey, MD · Children's Hospital and Regional Medical Center, Seattle, Washington, USA

  • Stuart Elborn, MD · Respiratory Medicine Group, Queen's University of Belfast, Belfast, Northern Ireland, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2012-11-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00909532 on ClinicalTrials.gov