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

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

Study Overview

• Status: Recruiting
• Conditions: Antidiuretic Hormone, Inappropriate Secretion
• Intervention / Treatment: Drug: Tolvaptan (SAMSCA)

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd; Phone Number: +81-6-6943-7722; Email: komaniwa.satoshi@otsuka.jp

Study Locations

• Japan
  • Osaka, Japan, 540-0021
    • Recruiting
    • Pharmacovigilance Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in Japan with hyponatremia in SIADH who are planned to be newly started on Samsca therapy

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Information (Adverse Event)	Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (Samsca), whether or not it is considered causally related to the Medicinal Product.	90 days from the initiation of tolvaptan treatment
Safety Information (Special Situations)	Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure;; Exposure during breastfeeding;; Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products);; Medication errors (e.g. patient took wrong dose);; Lack of therapeutic efficacy (e.g. the product doesn't work);; Occupational exposure (e.g.: nurse administering the product is exposed);; Cases of suspected transmission of infectious agents;; Use of suspected or confirmed falsified product(s) or quality defect of the product(s);; Withdrawal reactions;; Accidental exposure (e.g.: child takes parent's product);; Drug-drug/drug-food interactions;; Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population);; Disease progression/exacerbation of existing disease	90 days from the initiation of tolvaptan treatment
Safety Information (Number of off-Label Use)	Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.	90 days from the initiation of tolvaptan treatment
Safety Information (Serious Adverse Event)	Any adverse drug experience/event occurring at any dose which; results in death; is life-threatening; requires inpatient hospitalization or prolonged of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; is medically significant.	90 days from the initiation of tolvaptan treatment
Safety Information (Non-serious Adverse Events)	All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.	90 days from the initiation of tolvaptan treatment

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Yasuhiko Fukuta, PhD, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 7, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Water-Electrolyte Imbalance; Hypothalamic Diseases; Pituitary Diseases; Diabetes Insipidus; Hyponatremia; Inappropriate ADH Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Antidiuretic Hormone Receptor Antagonists; Tolvaptan
• Other Study ID Numbers: 156-101-00348

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No