Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
NCT ID: NCT05712746
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1600 participants
OBSERVATIONAL
2023-03-03
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
NCT01439009
A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
NCT00462670
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
NCT03962101
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
NCT00544869
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
NCT00043771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yasuhiko Fukuta, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pharmacovigilance Department
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Satoshi Komaniwa, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
263-101-00017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.