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, Heterozygous for F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy
A study for patients with Cystic Fibrosis using study drug VX-661 in combination with Ivacaftor
Sponsor: Vertex Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAP7951
U.S. Govt. ID: NCT02347657
Contact: Kristina Rivera: 212-305-4675 / klr2142@cumc.columbia.edu
Additional Study Information: This study is being done to learn more about the safety and effectiveness of study drug VX-661 in combination with ivacaftor in patients aged 12 years and older with Cystic Fibrosis (CF). In this Study there are two treatment groups. If the patient meets all the rules for being in the Study, they willbe in one of the two treatment groups. The patient will not know which treatment group they are enrolled in. If placed in treatment group A, they will receive one tablet of 100 mg VX-661/150 mg ivacaftor in themorning and one tablet of 150 mg ivacaftor in the evening. If placed in treatment group B, they willreceive a placebo tablet in the morning and a placebo tablet in the evening.
This study is closed
Claire Keating, MD
Do You Qualify?
Do you have a confirmed diagnosis of cystic fibrosis? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Kristina Rivera