Heart FailureNCT05712746
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.
An observational study of Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Samtasu for I.V. infusion
- Type of treatment
- Injection or infusion
- How many people
- 1,600 participants
- Where
- 1 siteJapan
- Study dates
- 3 Mar 2023to 31 May 2027
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Japan with volume overload in heart failure who are planned to be newly started on Samtasu therapy
Who may be able to join
- -
Who cannot join
- patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan
Trial locations and contacts
1 site in 1 country.
About this study
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
- Conditions
- Heart Failure
- Being tested
- Samtasu for I.V. infusion
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samtasu for I.V. infusionDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 14 days from the initiation of tolvaptan sodium phosphate treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start3 Mar 2023
- Primary completion7 May 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuhiko Fukuta, PhD, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712746
- Sponsor's protocol ID
- 263-101-00017
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.
- ClinicalTrials.gov ID
- NCT05712746
- Acronym / sponsor ID
- 263-101-00017
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Japan with volume overload in heart failure who are planned to be newly started on Samtasu therapy
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samtasu for I.V. infusionDrug: 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. | Drug | – |
Primary outcome
Safety information (Adverse Event)
Time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment
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.
Number of Special Situations
Time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment
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
Number of off-Label Use
Time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment
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.
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
Time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment
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.
Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
Time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment
Collecting the number of non-serious Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuhiko Fukuta, PhD study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety information (Adverse Event) (time frame: 14 days from the initiation of tolvaptan sodium phosphate treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.