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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyponatremia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tolvaptan

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.

Group Type EXPERIMENTAL

Tolvaptan

Intervention Type DRUG

Once Daily

Interventions

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Tolvaptan

Once Daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No