Trials / Recruiting
RecruitingNCT04790175
Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH
Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolvaptan (SAMSCA) | The usual adult dose of SAMSCA is 7.5 mg of tolvaptan once daily administered orally, increased stepwise to 60 mg daily until a desirable level of serum sodium concentration is achieved. |
Timeline
- Start date
- 2021-03-29
- Primary completion
- 2028-08-01
- Completion
- 2030-01-01
- First posted
- 2021-03-10
- Last updated
- 2025-03-24
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04790175. Inclusion in this directory is not an endorsement.