Phase 3
N=111
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT02449044 ↗Enrolled (actual)
111
Serious AEs
68.5%
Results posted
Jan 2016
Primary outcome: Primary: Participants With Adverse Events (AEs) — 105; 76; 73; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tolvaptan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Adverse Events (AEs) |
105; 76; 73; 19; 28; 19 | — |
| PRIMARY Participants With Laboratory Values Abnormalities Reported as TEAEs |
4; 4; 3; 3; 2; 3 | — |
| PRIMARY Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs |
6; 4; 3; 2; 2; 2 | — |
| PRIMARY Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) |
13; 8; 6; 3; 2; 2 | — |
| PRIMARY Participants With Body Weight Abnormalities Reported as TEAEs |
5; 1 | — |
| SECONDARY Mean Change From Baseline in Serum Sodium Measurements |
2.2; 5.2; 5.0; 5.0; 4.6; 4.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Participants With Severe Hyponatremia |
20.2; 9.1; 11.8; 13.6; 16.4; 14.5 | — |
| SECONDARY Change From Baseline in Percentage of Participants With Mild Hyponatremia |
53.5; 33.6; 28.2; 33.6; 30.9; 26.4 | — |
| SECONDARY Change From Baseline in Percentage of Participants With Normal Sodium Levels |
26.3; 57.3; 60.0; 52.7; 52.7; 59.1 | — |
| SECONDARY Percentage of Participants Requiring Prescription of Fluid Restriction |
14.47; 5.71 | — |
| SECONDARY Number of Participants Requiring Prescription of Hypertonic Saline |
2 | — |
| SECONDARY Percentage of Participants Requiring Prescription of Other Medicines |
— | — |
| SECONDARY Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline |
-0.5; -1.1; 0.2; 0.4; 0.5; 0.3 | 0.4922 |
| SECONDARY Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS) |
1.0; 0.4; 0.3; 0.4; -0.9; -0.3 | 0.1739 |
| SECONDARY Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS) |
-1.0; -1.0; -0.4; -2.0; -1.1; -2.7 | 0.2575 |
| SECONDARY Change From Baseline in the Hyponatremia Disease-specific Survey |
— | — |
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
- Age greater than or equal to 18 years.
- Ability to provide informed consent or assent.
- 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.
Data sourced from ClinicalTrials.gov (NCT02449044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.