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

NCT05712746 | Recruiting

• 1 other identifier: 263-101-00017
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Samtasu for I.V. infusion DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Pharmacovigilance Department

Osaka, 540-0021, Japan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yasuhiko Fukuta, PhD

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

CONTACT

+81-6-6943-7722; komaniwa.satoshi@otsuka.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 3, 2023
• Study Start: March 3, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)