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Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation

NCT00865904 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-08-28

Study results available
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Summary

The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Conditions

Interventions

DRUG

VX-809

Capsules

DRUG

Placebo

Placebo matched to VX-809 capsules.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Netherlands

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 NCT00865904 on ClinicalTrials.gov