39
Participants
Start Date
May 31, 2007
Primary Completion Date
August 31, 2008
Study Completion Date
August 31, 2008
Ivacaftor 25 mg/75 mg
25 mg or 75 mg q12h for a total of 28 days (Part 1)
Ivacaftor 75 mg/150 mg
75 mg or 150 mg q12h for a total of 28 days (Part 1)
Ivacaftor 150 mg or 250 mg
150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2)
Placebo
Given q12h for 28 days each in Part 1 and Part 2 of the study
University of Pittsburgh, Pittsburgh
Johns Hopkins Hospital, Baltimore
Cystic Fibrosis Pulmonary Research and Treatment Center, University of North Carolina at Chapel Hill, Chapel Hill
Stanford University Medical Center, Palo Alto
University of Alabama Hospital, Birmingham
Rainbow Babies and Children's Hospital, Cleveland
Division of Pulmonary, Allergy and Critical Care Medicine, University of Minnesota, Minneapolis
The Children's Hospital, Aurora
Pulmonary Critical Care, University of Washington, Seattle
Roy J. and Lucille A. Carver College of Medicine, The University of Iowa, Iowa City
Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston
Children's Hospital of Boston, Boston
The Children's Hospital of Philadelphia, Philadelphia
Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto
CF Clinic, Pediatric Pulmonology and Neonatology, Medical School of Hannover, Straße
Cystic Fibrosis Foundation
OTHER
Vertex Pharmaceuticals Incorporated
INDUSTRY