SIADHNCT01228682
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
An observational study of SIADH and Non-SIADH Hyponatremia, run by Otsuka Frankfurt Research Institute GmbH at 47 sites in 7 countries.
Trial summary
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice. A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 47 sitesin 7 countries
- Study dates
- Oct 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are treated with Samsca
Who may be able to join
- Patients who are treated with Samsca
Who cannot join
- Patients who have not signed the data consent form
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United Kingdom15 sites
Otsuka Study location 44.024
Birmingham
Otsuka Study location 44.019
Coventry
Otsuka Study location 44.003
Durham
Otsuka Study location 44-023
Hartlepool
Otsuka Study location 44.005
Kingston
Otsuka Study location 44.006
Liverpool
Otsuka Study location 44.016
Liverpool
Otsuka Study location 44-001
Manchester
Otsuka Study location 44.007
Manchester
Otsuka Study location 44.013
Manchester
Otsuka Study location 44.021
Nuneaton
Otsuka Study location 44-027
Oldham
Otsuka Study location 44.015
Oldham
Otsuka Study location 44-025
Preston
Otsuka Study location 44.004
Southampton
Germany14 sites
Otsuka Study location 49.007
Aachen
Otsuka Study location 49.004
Cologne
Otsuka Study location 49.016
Dresden
Otsuka Study location 49.011
Düsseldorf
Otsuka Study location 49.002
Hamburg
Otsuka Study location 49.012
Hanover
Otsuka Study location 49.018
Hanover
Otsuka Study Location 49-020
Heidelberg
Otsuka Study location 49-024
Heidelberg
Otsuka Study location 49.009
Lübeck
Otsuka Study location 49.017
Mannheim
Otsuka Study location 49-019
Regensberg
Otsuka Study location 49-021
Rostock
Otsuka study location 49-001
Würzburg
Spain8 sites
Otsuka Study location 34-007
Alicante
Otsuka Study location 34-014
Castellon
Otsuka Study location 34-015
Castellon
Otsuka Study location 34-013
Córdoba
Otsuka Study location 34-005
Madrid
Otsuka Study location 34.017
Majadahonda
Otsuka Study location 34-002
Seville
Otsuka Study location 34-012
Seville
Sweden4 sites
Otsuka Study Location 46.001
Gothenburg
Otsuka Study location 46-004
Karlstad
Otsuka Study location 46.002
Linköping
Otsuka Study location 46-003
Stockholm
Italy3 sites
Otsuka Study location 39-001
Cuneo
Otsuka Study location 39.007
Florence
Otsuka Study location 39.005
Siena
Denmark2 sites
Otsuka Study location 45-001
Copenhagen
Otsuka Study location 45-006
Holstebro
About this study
Official title: A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.
A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
Read the detailed description
Drug Utilisation Survey The drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the SmPC, patient age and patient gender distributions on a prescription level. In addition, the indication for use will be further categorised as
- SIADH
- Non-SIADH hyponatraemia
- Non-Hyponatraemia
Post-Authorisation Safety Study
Sodium levels at baseline and rate of sodium correction under therapy will be analysed. Safety findings will be described. The number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below:
- Renal safety
- Aquaresis-related adverse effects
- Serum sodium correction rate
- Glucose homeostasis
- Cardiovascular safety and hemodynamics
- Respiratory system
- Drug metabolism and drug interactions
- Drug exposure during pregnancy
- Paediatric safety
Subgroup analyses will be performed for all safety findings by indication subgroups (SIADH and other indications), subgroups according to SIADH-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.
- Conditions
- SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia
- Being tested
- Tolvaptan
- Keywords
- Sodium, SIADH, Hyponatremia, Vasopressin, Salt, Water
- Medical subject headings
- Inappropriate ADH Syndrome, Hyponatremia, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients who are treated with Samsca. | Not described Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age.
Measured: 3 years
Samsca sodium correction rates and adverse events in patients treated with Samsca
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SIADHStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228682
- Sponsor's protocol ID
- 156-09-101
- Status last verified
- Apr 2013
- First submitted
- 25 Oct 2010
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Estilo A, McCormick L, Rahman M. Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study. Adv Ther. 2021 Dec;38(12):5721-5736. doi: 10.1007/s12325-021-01947-9. Epub 2021 Oct 25.
PubMed 34693505
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice
- ClinicalTrials.gov ID
- NCT01228682
- Acronym / sponsor ID
- 156-09-101
- Conditions
- SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia
- Keywords
- Sodium, SIADH, Hyponatremia, Vasopressin, Salt, Water
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 26 Oct 2010 (estimated)
- 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.
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.
A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
Detailed description
Drug Utilisation Survey The drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the SmPC, patient age and patient gender distributions on a prescription level. In addition, the indication for use will be further categorised as
- SIADH
- Non-SIADH hyponatraemia
- Non-Hyponatraemia
Post-Authorisation Safety Study
Sodium levels at baseline and rate of sodium correction under therapy will be analysed. Safety findings will be described. The number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below:
- Renal safety
- Aquaresis-related adverse effects
- Serum sodium correction rate
- Glucose homeostasis
- Cardiovascular safety and hemodynamics
- Respiratory system
- Drug metabolism and drug interactions
- Drug exposure during pregnancy
- Paediatric safety
Subgroup analyses will be performed for all safety findings by indication subgroups (SIADH and other indications), subgroups according to SIADH-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who are treated with Samsca. | – | Drug: Tolvaptan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are treated with Samsca
Key inclusion criteria (1 listed)
- Patients who are treated with Samsca
Key exclusion criteria (1 listed)
- Patients who have not signed the data consent form
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 |
|---|---|---|
| TolvaptanAlso: SamscaSamsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician. | Drug | Patients who are treated with Samsca. |
Primary outcome
Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age.
Time frame: 3 years
Samsca sodium correction rates and adverse events in patients treated with Samsca
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Derived from this study: PubMed 34693505Estilo A, McCormick L, Rahman M. Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study. Adv Ther. 2021 Dec;38(12):5721-5736. doi: 10.1007/s12325-021-01947-9. Epub 2021 Oct 25.
Related trials for SIADH
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Recruiting
Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
Hyponatremia, Syndrome of Inappropriate Antidiuresis
Active, not recruiting
Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage
Hyponatremia, Subarachnoid Hemorrhage
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
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.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIADH and Non-SIADH Hyponatremia, run by Otsuka Frankfurt Research Institute GmbH at 47 sites in 7 countries.
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: status not confirmed, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United Kingdom, Germany, Spain, Sweden, Italy and 2 more countries. 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?
Results are not available in the source record.
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?
Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228682, which also lists 1 linked publication.
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 1 May 2013.