A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
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|ClinicalTrials.gov Identifier: NCT02442674|
Recruitment Status : Withdrawn (Trial withdrawn due to inability to meet the trial objectives (Pilot).)
First Posted : May 13, 2015
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyponatremia||Drug: Tolvaptan Other: Placebo||Phase 3|
The purpose of the study is to also assess tolvaptan's pharmacokinetics (PK) and its effect on fluid balance in children and adolescent subjects with euvolemic or hypervolemic hyponatremia. Subjects who are diagnosed with euvolemic or hypervolemic hyponatremia (serum sodium < 130 mEq/L [mmol/L]) that persists despite initial standard background therapy (eg, including fluid restriction) are eligible to be screened for participation in this trial. Subjects who demonstrate prior resistance to vasopressin antagonist therapy will be excluded. All potential subjects must be deemed by the investigator as likely to benefit from a therapy that raises serum sodium levels.
Subjects will be required to be in a hospital setting during initiation or titration of tolvaptan. Overall, in this trial, subjects will undergo treatment with tolvaptan or placebo for 30 (+2) days and a post-last dose follow-up phase of 14 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Phase 3b,Multicenter,Randomized,Double-blind,Placebo-controlled Trial of the Safety,Efficacy,and Pharmacokinetics of Titrated Oral SAMSCA®(Tolvaptan) in Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||June 22, 2017|
|Actual Study Completion Date :||June 22, 2017|
Active Comparator: Tolvaptan
Tolvaptan (3.75 mg, 7.5 mg, 15 mg, 30 mg, 60 mg dose daily depending on age and weight)
Tolvaptan 3.75-, 7.5-, 15-, and 30-mg Tablets.
Dosage: Depending on age, weight and serum sodium response:
Tablet (3.75 mg - 60 mg daily) Frequency: Once daily Duration: 30 (+2) days
Other Name: SAMSCA
Placebo Comparator: Placebo
Placebo tablet matching active drug
Placebo tablet matching active drug
- Change in serum sodium concentration [ Time Frame: Daily up to day 4 ]The average daily area under the curve (AUC) of change from baseline in serum sodium level up to Day 4 within the double-blind treatment period.
- Change of average daily AUC from baseline at each visit in serum sodium level. [ Time Frame: Daily up to Day 30 ]
- Change from baseline in serum sodium concentration at Day 4. [ Time Frame: Day 4 ]
- Change from baseline in serum sodium concentration at Day 30. [ Time Frame: Daily up to Day 30 ]
- Percentage of subjects who require rescue therapy or fluid restriction at any time during the double-blind treatment period. [ Time Frame: Daily up to Day 30 ]
- Changes from baseline in ALT, AST and Total Bilirubin [ Time Frame: Daily up to Day 30 ]
- Clinically significant changes in vital signs. [ Time Frame: Daily up to Day 30 ]
- Incidence of dehydration AEs. [ Time Frame: Daily up to Day 30 ]
- Tanner staging progression score (at 30 days) [ Time Frame: Daily up to Day 30 ]
- Percentage of subjects with overly rapid correction in serum sodium ( ≥ 12 mmol/L in 24 hours). [ Time Frame: Daily up to Day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442674
|Study Director:||Ann Dandurand, MD||Otsuka Pharmaceutical Development & Commercialization, Inc.|