Trials / Terminated
TerminatedNCT02012959
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA ® (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subjects Hospitalized With Euvolemic or Hypervolemic Hyponatremia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 4 Weeks – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolvaptan |
Timeline
- Start date
- 2015-09-22
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
- First posted
- 2013-12-17
- Last updated
- 2018-09-26
- Results posted
- 2018-08-28
Locations
7 sites across 3 countries: United States, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT02012959. Inclusion in this directory is not an endorsement.