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

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

Detailed Description
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Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CK-LX3401<br>Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia. | |
| CK-LX3405<br>Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia | |
| CK-LX3430<br>Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials. |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline. |  | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Euvolemic Hyponatremia, Hypervolemic Hyponatremia, SIADH, Serum Sodium