Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CardioKine Inc.
• Collaborators: Biogen; Cardiokine Biopharma, LLC

Criteria

Inclusion Criteria:

• Written informed consent

• Men or women aged 18 or older

• Diagnosis of euvolemic hyponatremia (120 ≤ Na+<130 mEq/L)

• Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment

Exclusion Criteria:

• Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed

• Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)

• Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)

• Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion

• Hyponatremia as a result of any medication that can safely be withdrawn

• Hyponatremia due to hypothyroidism or adrenal insufficiency

• Diagnosis of psychogenic polydipsia

• Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan

• Use of radiotherapy and chemotherapy within 2 wks of randomization

• Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study

• Supine systolic arterial blood pressure of ≤ 90 mmHg

• Serum creatinine >3.0 mg/dL

• History of uncontrolled type 2 diabetes mellitus

• Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate with sudden shifts in fluid volumes and cardiac filling pressures

• Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure

• History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening

• History of cerebral vascular accident (CVA) within 60 days prior to screening

• Established diagnosis of nephrotic syndrome

• Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis

• Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)

• History of alcohol abuse or illicit drug use within the past 6 months

• Terminally ill or moribund condition with little chance of short-term survival

• Receiving vasopressin or its analogs for treatment of any condition

• Known allergy to any vasopressin antagonist

• Previous participation in a lixivaptan study

• Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit

• Unable to take oral medications