CompletedNot Applicable

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

United States135 participantsStarted 2010-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.

Timeframe: 28 weeks

NCT IDNCT01056848

SponsorCardioKine Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-06