International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430

Completed

Conditions studied: Hyponatremia With Normal Extracellular Fluid Volume, Hyponatremia With Excess Extracellular Fluid Volume

In brief

To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia

Key facts

Study ID: NCT01056848
Run by: CardioKine Inc.
People needed: 135
Starts: 2010-01-01
Last updated by the study team: 2011-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women 18 years of age or older
Ability to provide informed consent or assent
Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy

You may not qualify if…

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, artificial 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

Where it is running

Torrance Clinical Research — Lomita, California, United States
Innovative Research of West Florida — Clearewater, Florida, United States
Fleming Island Center for Clinical Research — Fleming Island, Florida, United States
Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
Millenium Psychiatric Associates, LLC — Creve Cour, Missouri, United States
Internal Medical Associates of Grand Island, PC — Grand Island, Nebraska, United States

Full record on ClinicalTrials.gov

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