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Completed Phase 3 Interventional Results available

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

ClinicalTrials.gov ID: NCT02347657

Public ClinicalTrials.gov record NCT02347657. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 28, 2026, 7:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Study identification

NCT ID
NCT02347657
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Enrollment
510 participants

Conditions and interventions

Interventions

  • VX-661 Plus Ivacaftor Combination Drug
  • Ivacaftor Drug
  • VX-661 Plus Ivacaftor Combination Placebo Drug
  • Ivacaftor placebo Drug

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2014
Primary completion
Jan 19, 2017
Completion
Jan 19, 2017
Last update posted
Jun 11, 2018

2015 – 2017

United States locations

U.S. sites
27
U.S. states
19
U.S. cities
27
Facility City State ZIP Site status
Not listed Little Rock Arkansas
Not listed Long Beach California
Not listed Denver Colorado
Not listed Orlando Florida
Not listed Tampa Florida
Not listed Chicago Illinois
Not listed Peoria Illinois
Not listed Boston Massachusetts
Not listed Minneapolis Minnesota
Not listed St Louis Missouri
Not listed Manchester New Hampshire
Not listed Long Branch New Jersey
Not listed Albuquerque New Mexico
Not listed Albany New York
Not listed Buffalo New York
Not listed New Hyde Park New York
Not listed Rochester New York
Not listed Syracuse New York
Not listed Akron Ohio
Not listed Columbus Ohio
Not listed Oklahoma City Oklahoma
Not listed Charleston South Carolina
Not listed Sioux Falls South Dakota
Not listed Fort Worth Texas
Not listed Tyler Texas
Not listed Seattle Washington
Not listed Milwaukee Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02347657, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2018 · Synced Jun 28, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02347657 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →