Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.

Heart Failure Clinical Trial

Official title:

Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712746
• Other study ID #: 263-101-00017
• Status: Recruiting
• Start date: March 3, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
• Phone: +81-6-6943-7722
• Email: komaniwa.satoshi[@]otsuka.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: May 31, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Samtasu 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.

Locations

Country	Name	City	State
Japan	Pharmacovigilance Department	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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 (see Annex ?, 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.	14 days from the initiation of tolvaptan sodium phosphate treatment
Primary	Number of Special Situations	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	14 days from the initiation of tolvaptan sodium phosphate treatment
Primary	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 nonauthorized population categories not indicated in the label.	14 days from the initiation of tolvaptan sodium phosphate treatment
Primary	Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)	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.	14 days from the initiation of tolvaptan sodium phosphate treatment
Primary	Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)	Collecting the number of non-serious Adverse Events	14 days from the initiation of tolvaptan sodium phosphate treatment