Clinical trial NCT02449044: International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
Official title: International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia: Extension to Studies 156-02-235 and 156-03-238 to Assess One-year Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Keywords: Hyponatremia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Ability to provide informed consent or assent.
3. Prior successful participation in a tolvaptan hyponatremia trial termination with evidence of continued need or desire for therapy.

Exclusion Criteria:

* A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient.
* Hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy.
* Hyponatremia due to reversible medical condition or therapy
* Conditions associated with an independent imminent risk of morbidity and mortality
* Conditions which confound the assessment of endpoints.

Primary outcomes:
measure: Participants With Adverse Events (AEs)
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Participants With Laboratory Values Abnormalities Reported as TEAEs
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Participants With Body Weight Abnormalities Reported as TEAEs
timeFrame: Baseline to Post-Week 214 follow-up visit
Secondary outcomes:
measure: Mean Change From Baseline in Serum Sodium Measurements
timeFrame: Baseline of parent trial to Week 214
measure: Change From Baseline in Percentage of Participants With Severe Hyponatremia
timeFrame: Baseline to Week 214
measure: Change From Baseline in Percentage of Participants With Mild Hyponatremia
timeFrame: Baseline to Week 214
measure: Change From Baseline in Percentage of Participants With Normal Sodium Levels
timeFrame: Baseline to Week 214
measure: Percentage of Participants Requiring Prescription of Fluid Restriction
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Number of Participants Requiring Prescription of Hypertonic Saline
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Percentage of Participants Requiring Prescription of Other Medicines
timeFrame: Baseline to Post-Week 214 follow-up visit
measure: Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline
timeFrame: Baseline to Week 214
measure: Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS)
timeFrame: Baseline to Week 214
measure: Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS)
timeFrame: Baseline to Week 214
measure: Change From Baseline in the Hyponatremia Disease-specific Survey
timeFrame: Baseline to Week 214
Other outcomes:
Locations:
Study officials:
References:
citation: Berl T, Quittnat-Pelletier F, Verbalis JG, Schrier RW, Bichet DG, Ouyang J, Czerwiec FS; SALTWATER Investigators. Oral tolvaptan is safe and effective in chronic hyponatremia. J Am Soc Nephrol. 2010 Apr;21(4):705-12. doi: 10.1681/ASN.2009080857. Epub 2010 Feb 25.