HyponatremiaPhase 3NCT02020278
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
A Phase 3 study testing Tolvaptan in people with Hyponatremia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 23 sites in 8 countries.
Trial summary
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 22 Apr 2016to 23 Oct 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Optional Tolvaptan Treatment Component (per treatment cycle)
- Eligibility Criteria:
- Male and female participants ≥ 4 years of age (or per local Health Authority age restrictions) and ≥ 10 kilograms (kg).
- Participant must have been off treatment with the investigational medicinal product for at least 7 days following the end of treatment in the previous tolvaptan trial for hyponatremia (euvolemic or hypervolemic).
- Persistent dilutional (euvolemic or hypervolemic) hyponatremia defined as being documented as present for at least 48 hours, evidenced by at least 2 serum sodium assessments < 130 milliequivalents (mEq)/liter (L) (millimole [mmol]/L) drawn at least 12 hours apart (these values can be documented using historical values previously obtained per standard of care); a third (STAT) serum sodium assessment < 130 mEq/L (mmol/L), which will serve as the baseline value for efficacy endpoints, had to be obtained within 2 to 4 hours prior to the first dose of tolvaptan.
- Ability to swallow tablets.
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- Ability to maintain adequate fluid intake whether orally or via intravenous support with adequate monitoring.
- Ability to comply with all requirements of the trial.
- Trial-specific written informed consent/assent obtained from a parent/legal guardian or legally acceptable representative, as applicable per age of participant or local laws, prior to the initiation of any protocol-required procedures. In addition, the participant as required by local laws must provide informed assent at the pretreatment baseline for this trial and must be able to understand that he or she can withdraw from the trial at any time. All informed consent/assent procedures must be in accordance with the trial center's Institutional Review Board/Independent Ethics Committee and local regulatory requirements.
- Ability to commit to remain fully abstinent (periodic abstinence [for example, calendar, ovulation, symptothermal, post-ovulation methods] or withdrawal are not acceptable methods of contraception) or practice double-barrier birth control during the trial and for 30 days following the last dose of IMP for sexually active females of childbearing potential.
- Ineligibility Criteria:
- Had evidence of hypovolemia or intravascular volume depletion (for example, hypotension, clinical evidence of volume depletion, response to saline challenge); if the participant had systolic blood pressure or heart rate outside of the normal range for that age, then volume status was to be specifically clinically assessed to rule out volume depletion.
- Had serum sodium < 120 mEq/L (mmol/L), with or without associated neurologic impairment (that is, symptoms such as apathy, confusion, or seizures).
- Use of potent CYP3A4 inhibitors in participants ≤ 50 kg or moderate CYP3A4 inhibitors in participants < 20 kg.
- Lacked free access to water (inability to respond to thirst) or without ICU-level fluid monitoring and management.
- Had a history or current diagnosis of nephrotic syndrome.
- Had transient hyponatremia likely to resolve (for example, head trauma or post-operative state).
- Had hyperkalemia defined as serum potassium above the upper limit of normal (ULN) for the appropriate pediatric age range.
- Had estimated glomerular filtration rate (eGFR) < 30 milliliters (mL)/minute (min)/1.73 meters squared (m^2) calculated by the following equation: eGFR (mL/min/1.73 m^2) = 0.413 x height (centimeter [cm])/serum creatinine (mg/deciliter [dL]).
- Had acute kidney injury defined as: Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 micromoles [μmol]/L) within 48 hours; or increase in serum creatinine to ≥ 1.5 times baseline, which was known or presumed to have occurred within the prior 7 days; or urine volume < 0.5 mL/kg/hour for 6 hours.
- Had severe or acute neurological symptoms requiring other intervention (for example, hyperemesis, obtundation, seizures).
- Had had treatment for hyponatremia with:
- Hypertonic saline (including normal saline challenge) within 8 hours of qualifying sodium assessments;
- Urea, lithium, demeclocycline, conivaptan, or tolvaptan within 4 days of qualifying serum sodium assessments;
- Other treatment for the purpose of increasing serum sodium concurrent with dosing of trial medication
- Had anuria or urinary outflow obstruction, unless the participant was, or could be, catheterized during the trial.
- Had a history of drug or medication abuse within 3 months prior to the pretreatment visit or current alcohol abuse.
- Had a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril).
- Had psychogenic polydipsia (participants with other psychiatric illness may be included per medical monitor approval).
- Had uncontrolled diabetes mellitus, defined as fasting glucose > 300 mg/dL (16.7 mEq/L [mmol/L]).
- Had screening liver function values > 3 x ULN.
- Had cirrhosis and met any of the following conditions: a major gastrointestinal bleed within the past 6 months, evidence of active bleeding (for example, epistaxis, petechiae/purpura, hematuria, or hematochezia), platelet count < 50,000/μL, or use of concomitant medications known to increase bleeding risk.
- Had hyponatremia due to the result of any medication that can safely be withdrawn (for example, thiazide diuretics).
- Had hyponatremia (for example, hyponatremia in the setting of adrenal insufficiency, untreated hypothyroidism, or hypotonic fluid administration) that is most appropriately corrected by alternative therapies.
- Was currently pregnant or breastfeeding.
- Had any medical condition that, in the opinion of the investigator, could interfere with evaluation of the trial objectives or safety of the participants.
- Was deemed unsuitable for trial participation in the opinion of the investigator.
- Participation in another investigational drug trial within the past 30 days, without prior approval from the sponsor medical monitor.
- Participants < 4 years of age (or per local Health Authority age restrictions), weight < 10 kg, or who were unable to swallow tablets.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States11 sites
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Cleveland, Ohio, 44106
Study site
Grand Rapids, Michigan, 49503
Study site
Kansas City, Missouri, 64108
Study site
New York, New York, 10032
Study site
Philadelphia, Pennsylvania, 19104
Study site
Seattle, Washington, 98105
Study site
Stony Brook, New York, 11794-8111
Study site
The Bronx, New York, 10467
Study site
Washington D.C., District of Columbia, 20010
Italy4 sites
Study site
Genova, 16147
Study site
Naples, 80131
Study site
Palermo, 90134
Study site
Rome, 00165
About this study
Official title: A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA® (Tolvaptan)
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).
Read the detailed description
Core Safety Follow-up Component
- For all participants: To evaluate the post-treatment safety follow-up of children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial.
Optional Tolvaptan Treatment Component
- For participants who receive optional tolvaptan treatment: To demonstrate that tolvaptan safely and effectively achieves and maintains increased serum sodium concentrations in children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia when used for both multiple short-term treatments, and/or longer chronic treatments.
- Conditions
- Hyponatremia
- Being tested
- Tolvaptan
- Keywords
- Hyponatremia, Euvolemic, Hypervolemic, Serum sodium, Dilutional hyponatremia, Electrolyte abnormality, Electrolyte imbalance, Metabolic disease, Water-Electrolyte Imbalance
- Medical subject headings
- Hyponatremia, Metabolic Diseases, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called SAMSCA®
Tolvaptan 3.75-, 7.5-, 15-, and 30-mg spray-dried tablets. Dosage: Depending on age and weight, Tablet (3.75 mg - 60 mg daily). Frequency: Once daily.
Duration: Participants may be eligible to receive short-term or long-term optional tolvaptan treatment at any time during their participation in the trial, with one or more treatment cycles over a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Experimental | Participants enrolled in this trial were eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment.
Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg. Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: Baseline, Month 6
Secondary outcomes (13)
Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: Month 6
Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: Month 6
Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: Month 6
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6
The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the GCS total score is presented.
Measured: Baseline, Month 6
Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6
The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the physical health dimension is presented.
Measured: Baseline, Month 6
Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6
The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented.
Measured: Baseline, Month 6
Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6
The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented.
Measured: Baseline, Month 6
Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: Month 6
Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
Measured: 8 Weeks
Participants With A Tanner Staging Score Of 1 At Month 6
Tanner Staging assessment consists of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. Staging was based on a single score summarizing the domains (not individual domain scores). Stages range from 1-5, with 1 indicating preadolescent and 5 adult. Participants with a Tanner staging score of 1 (preadolescent) at Month 6 are reported.
Measured: Month 6
Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6
Changes from baseline in growth percentiles for body height and weight were calculated and are reported.
Measured: Baseline, Month 6
Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for ALT and AST during the Core Safety Follow-up Component of the trial. Results are reported in units/liter (U/L).
Measured: Baseline, Month 2
Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for bilirubin during the Core Safety Follow-up Component of the trial. Results are reported in micromoles (umol)/L.
Measured: Baseline, Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start22 Apr 2016
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Why it stopped: Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020278
- Sponsor's protocol ID
- 156-11-294
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2013
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA® (Tolvaptan)
- ClinicalTrials.gov ID
- NCT02020278
- Acronym / sponsor ID
- 156-11-294
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia, Euvolemic, Hypervolemic, Serum sodium, Dilutional hyponatremia, Electrolyte abnormality, Electrolyte imbalance, Metabolic disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).
Detailed description
Core Safety Follow-up Component
- For all participants: To evaluate the post-treatment safety follow-up of children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia who have previously participated in a tolvaptan hyponatremia trial.
Optional Tolvaptan Treatment Component
- For participants who receive optional tolvaptan treatment: To demonstrate that tolvaptan safely and effectively achieves and maintains increased serum sodium concentrations in children and adolescent participants with dilutional (euvolemic or hypervolemic) hyponatremia when used for both multiple short-term treatments, and/or longer chronic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan | Experimental | Drug: TolvaptanParticipants enrolled in this trial were eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (39 listed)
- Optional Tolvaptan Treatment Component (per treatment cycle)
- Male and female participants ≥ 4 years of age (or per local Health Authority age restrictions) and ≥ 10 kilograms (kg).
- Participant must have been off treatment with the investigational medicinal product for at least 7 days following the end of treatment in the previous tolvaptan trial for hyponatremia (euvolemic or hypervolemic).
- Persistent dilutional (euvolemic or hypervolemic) hyponatremia defined as being documented as present for at least 48 hours, evidenced by at least 2 serum sodium assessments < 130 milliequivalents (mEq)/liter (L) (millimole [mmol]/L) drawn at least 12 hours apart (these values can be documented using historical values previously obtained per standard of care); a third (STAT) serum sodium assessment < 130 mEq/L (mmol/L), which will serve as the baseline value for efficacy endpoints, had to be obtained within 2 to 4 hours prior to the first dose of tolvaptan.
- Ability to swallow tablets.
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: SAMSCA®Tolvaptan 3.75-, 7.5-, 15-, and 30-mg spray-dried tablets. Dosage: Depending on age and weight, Tablet (3.75 mg - 60 mg daily). Frequency: Once daily. Duration: Participants may be eligible to receive short-term or long-term optional tolvaptan treatment at any time during their participation in the trial, with one or more treatment cycles over a 6-month period. | Drug | Tolvaptan |
Primary outcome
Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered
Time frame: Baseline, Month 6
No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
13 secondary outcomes
Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment
Time frame: Month 6
Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan
Time frame: Month 6
Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment
Time frame: Month 6
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6
Time frame: Baseline, Month 6
Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6
Time frame: Baseline, Month 6
Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6
Time frame: Baseline, Month 6
Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6
Time frame: Baseline, Month 6
Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan
Time frame: Month 6
Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks
Time frame: 8 Weeks
Participants With A Tanner Staging Score Of 1 At Month 6
Time frame: Month 6
Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6
Time frame: Baseline, Month 6
Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2
Time frame: Baseline, Month 2
Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2
Time frame: Baseline, Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Small studies with less than 25 participants are excluded from data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Hyponatremia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 23 sites in 8 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 0 inclusion and 39 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: stopped early, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Italy, Germany, Romania, Belgium and 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered (time frame: Baseline, Month 6). 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 17 Apr 2020.