Trials / Completed
CompletedNCT03048747
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolvaptan Oral Tablet | Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. |
Timeline
- Start date
- 2017-03-02
- Primary completion
- 2019-03-19
- Completion
- 2019-03-19
- First posted
- 2017-02-09
- Last updated
- 2020-11-02
- Results posted
- 2020-11-02
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03048747. Inclusion in this directory is not an endorsement.