International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

Otsuka

Status and phase: Completed; Phase 3

Conditions: Hyponatremia

Treatments: Drug: Tolvaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449044

156-03-244

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Tolvaptan

Experimental group

Description:

Enrolled subjects began treatment with 15 mg tolvaptan QD. A titration between target doses of 15 mg, 30 mg, or 60 mg of trial medication was based on the subject's change in serum sodium concentration and clinical tolerance of the trial medication.

Treatment:

Drug: Tolvaptan