20
Participants
Start Date
July 1, 2022
Primary Completion Date
April 12, 2029
Study Completion Date
April 12, 2029
Tolvaptan (OPC-41061)
Tolvaptan suspension will be administered orally or via nasogastric tube at doses of 0.15 mg/kg once daily in the AM, 0.30 mg/kg once daily in the AM, 0.5 mg/kg once daily in the AM, 0.75 mg/kg split dose (0.5 mg/kg AM and 0.25 mg/kg 8 hours later), and 1 mg/kg split dose (0.67 mg/kg AM and 0.33 mg/kg 8 hours later) based on age. Treatment duration is 2 years.
RECRUITING
UZ Leuven, Leuven
RECRUITING
Universitair Ziekenhuis Gent, Ghent
RECRUITING
Children's National Medical Center, Washington D.C.
RECRUITING
Johns Hopkins Pediatric Specialty Clinic, Baltimore
NOT_YET_RECRUITING
Emory University Hospital, Atlanta
WITHDRAWN
Hospital Universitario Virgen del Rocio, Seville
RECRUITING
Cleveland Clinic, Cleveland
WITHDRAWN
Universitätsklinikum Köln, Cologne
RECRUITING
Mayo Clinic - Rochester, Rochester
RECRUITING
Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology, Chicago
WITHDRAWN
Primary Children's Hospital, Salt Lake City
RECRUITING
C.S. Mott Children's Hospital, Ann Arbor
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
WITHDRAWN
"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw
WITHDRAWN
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa, Bialystok
RECRUITING
Universitat de Barcelona - Hospital Sant Joan de Deu Barcelona (HSJDB), Esplugues de Llobregat
RECRUITING
Hospital Universitari Vall D Hebron, Barcelona
RECRUITING
Great Ormond Street Hospital for Children NHS Trust, London
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY