Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in SIADH
Launched by OTSUKA PHARMACEUTICAL CO., LTD. · Mar 7, 2021
Trial Information
Current as of May 10, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called tolvaptan, which is used to help manage a condition known as hyponatremia caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In simpler terms, this condition occurs when your body has too much of a hormone that helps control water balance, leading to low sodium levels in the blood. The aim of the trial is to confirm that tolvaptan is safe for patients dealing with this issue in Japan.
To participate in this study, individuals must have a confirmed diagnosis of SIADH according to specific medical guidelines. The trial is open to all adults, and there are currently no limitations based on age or gender. If you join the study, you can expect to be monitored for how well the medication works and any side effects it may cause. The researchers are eager to ensure that tolvaptan is a safe and effective option for people facing this challenging condition.
Gender
ALL
Eligibility 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:
- • -
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company headquartered in Tokyo, Japan, dedicated to the research, development, and commercialization of innovative pharmaceuticals and nutraceuticals. Founded in 1964, Otsuka focuses on addressing unmet medical needs across various therapeutic areas, including psychiatry, neurology, oncology, and cardiovascular health. With a commitment to advancing healthcare through scientific innovation, Otsuka leverages its expertise in drug development and strategic partnerships to deliver groundbreaking therapies that improve patients' quality of life. The company's dedication to sustainability and ethical practices underscores its mission to contribute positively to global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Osaka, , Japan
Patients applied
Trial Officials
Yasuhiko Fukuta, PhD
Study Director
Otsuka Pharmaceutical Co., Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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