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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Samtasu for I.V. infusion

• Study Type: Observational
• Enrollment (Estimated): 1600

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
    • Contact: Satoshi Komaniwa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in Japan with volume overload in heart failure who are planned to be newly started on Samtasu therapy

Description

Inclusion Criteria:

-

Exclusion Criteria:

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

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 (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.	14 days from the initiation of tolvaptan sodium phosphate treatment
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
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
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
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

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 3, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 3, 2023

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: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 263-101-00017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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