Antidiuretic Hormone, Inappropriate Secretion Clinical Trial
Official title:
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan
| NCT number | NCT04790175 |
| Other study ID # | 156-101-00348 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 29, 2021 |
| Est. completion date | January 2030 |
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
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | January 2030 |
| Est. primary completion date | August 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Pharmacovigilance Department | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |