An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia

PHASE3TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 22, 2016

Primary Completion Date

October 23, 2017

Study Completion Date

October 23, 2017

Conditions
Hyponatremia
Interventions
DRUG

Tolvaptan

"Tolvaptan 3.75-, 7.5-, 15-, and 30-mg spray-dried tablets. Dosage: Depending on age and weight, Tablet (3.75 mg - 60 mg daily). Frequency: Once daily.~Duration: Participants may be eligible to receive short-term or long-term optional tolvaptan treatment at any time during their participation in the trial, with one or more treatment cycles over a 6-month period."

Trial Locations (23)

9000

Ghent

10032

New York

10467

The Bronx

16147

Genova

19104

Philadelphia

20010

Washington D.C.

28007

Madrid

30322

Atlanta

44106

Cleveland

49503

Grand Rapids

64108

Kansas City

80045

Aurora

80131

Naples

90134

Palermo

98105

Seattle

550166

Sibiu

11794-8111

Stony Brook

5 150 06

Prague

Unknown

Erlangen

04289

Leipzig

00165

Rome

022238

Bucharest

WC1N 3JH

London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY