CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
VX-809 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00865904
NCT00865904Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of VX-809 to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of VX-809 in Cystic Fibrosis Subjects Homozygous for the ∆F508-CFTR Gene Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Mar 19, 2009·Updated Aug 28, 2015

In Brief

A Phase 2 clinical trial evaluating VX-809 and Placebo for Cystic Fibrosis. Completed, enrolled 93 participants across 25 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBelgium, Canada, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2009
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.3 years ago

Interventions

VX-809drug

Capsules

Placebodrug

Placebo matched to VX-809 capsules.