Survey on the safety of tolvaptan for hyponatremia in SIADH patients
Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
This study is testing if tolvaptan is safe for people in Japan who have low sodium levels due to SIADH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Osaka, Osaka) |
| Trial ID | NCT04790175 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the safety of tolvaptan, a medication used to treat hyponatremia, in patients diagnosed with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan. The study will collect data on the drug's use and its effects in real-world settings, focusing on patient outcomes and safety profiles. Participants will be monitored for any adverse effects or complications associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a confirmed diagnosis of SIADH as per the relevant diagnostic guidelines.
Not a fit: Patients without a diagnosis of SIADH or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of tolvaptan for patients suffering from hyponatremia due to SIADH.
How similar studies have performed: Previous studies have shown positive outcomes with tolvaptan in similar patient populations, indicating a potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2018" Exclusion Criteria: \-
Where this trial is running
Osaka, Osaka
- Pharmacovigilance Department — Osaka, Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
- Email: komaniwa.satoshi@otsuka.jp
- Phone: +81-6-6943-7722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.