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Heart failure drug samtasu put to the test in 1,600-Patient safety survey

NCT ID NCT05712746

Disease control Sponsor: Otsuka Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study monitors the safety of the intravenous drug Samtasu (tolvaptan sodium phosphate) in people with heart failure who have fluid overload. Researchers will track side effects, including serious events and off-label use, in about 1,600 patients. The goal is to confirm the drug's safety in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Samtasu (tolvaptan sodium phosphate)
What this could lead to
If this study shows Samtasu is safe in a broad group of heart failure patients, it could support its continued use to help remove excess fluid and ease symptoms.
What could go wrong
This is an observational safety study, not a test of effectiveness. It may reveal unexpected side effects or find that the drug does not work well in certain patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Exclusion Criteria: * patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Pharmacovigilance Department

    Osaka, 540-0021, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.