Survey on the use of Samtasu in heart failure patients with volume overload
Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
This study is testing if the heart medication Samtasu is safe and effective for people with heart failure who have too much fluid in their bodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Osaka) |
| Trial ID | NCT05712746 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the safety of tolvaptan sodium phosphate, marketed as Samtasu, in patients experiencing volume overload due to heart failure. The study will involve monitoring patients receiving I.V. infusion of Samtasu to gather real-world data on its effects and safety profile. By focusing on post-marketing results, the study seeks to provide insights into the drug's performance in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with heart failure who are experiencing volume overload.
Not a fit: Patients with a known hypersensitivity to tolvaptan sodium phosphate or tolvaptan will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment options for patients with heart failure.
How similar studies have performed: While this study focuses on a specific post-marketing survey, similar observational studies have previously shown success in confirming the safety and efficacy of treatments in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Exclusion Criteria: * patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan
Where this trial is running
Osaka
- Pharmacovigilance Department — Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
- Email: komaniwa.satoshi@otsuka.jp
- Phone: +81-6-6943-7722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.