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COMPLETEDPHASE3

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

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

NCT02449044•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

May 1, 2004

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

January 21, 2016

Enrollment

111

ACTUAL participants

Conditions

Hyponatremia

Interventions

Tolvaptan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges

Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

Delirium Related to Proton Pump Inhibitors Use

Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery

Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia