Heart Failure
Conditions
Brief summary
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
Interventions
DRUGSamtasu for I.V. infusion
Drug: 8 mg/vial or 16mg/vial Dosage and Administration: The usual adult dosage of tolvaptan sodium phosphate is 16 mg once daily and intravenously infused over 1 hour.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
* patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety information (Adverse Event) | 14 days from the initiation of tolvaptan sodium phosphate treatment | 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 (see Annex Ⅳ, 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, whether or not it is considered causally related to the Medicinal Product. |
| Number of Special Situations | 14 days from the initiation of tolvaptan sodium phosphate treatment | Collecting any 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 |
| Number of off-Label Use | 14 days from the initiation of tolvaptan sodium phosphate treatment | 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 nonauthorized population categories not indicated in the label. |
| Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening) | 14 days from the initiation of tolvaptan sodium phosphate treatment | Collecting the number of 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. |
| Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event) | 14 days from the initiation of tolvaptan sodium phosphate treatment | Collecting the number of non-serious Adverse Events |
Countries
Japan
Contacts
STUDY_DIRECTORYasuhiko Fukuta, PhD
Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed