A clinical trial to study the effects of lixivaptan in patients with Euvolemic Hyponatrmeia.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Written informed consent.
2. Men or women aged 18 or older.
3. Diagnosis of euvolemic hyponatremia (Na+<130 mEq/L).
4. Hospitalized or willing to be admitted to a monitored setting for approximately the first 48-72 hours of treatment.

Exclusion Criteria

1. Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
2. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., lethargy, coma, seizures)
3. Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
4. Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
5. Hyponatremia as a result of any medication that can safely be withdrawn
6. Hyponatremia due to hypothyroidism or adrenal insufficiency
7. Current diagnosis of psychogenic polydipsia
8. Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or vasopressin antagonist.
9. Use of radiotherapy and/or chemotherapy within 2 wks of randomization
10. Serum creatinine >3.0 mg/dL (265.2 mol/L)
11. Uncontrolled diabetes mellitus as defined by the Investigators (e.g. HbA1c > 9%)
12. Severe pulmonary artery hypertension: subjects whose condition is expected to deteriorate
13. Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
14. ST-segment elevation myocardial infarction (STEMI) within 30-Days or active myocardial ischemia at the time of enrollment
15. History of cerebral vascular accident (CVA) within 30 days prior to screening
16. Established diagnosis of nephrotic syndrome
17. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
18. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)
19. History of chronic drug/medication abuse within the past 6 months; or current alcohol abuse
20. Terminally ill or moribund condition with little chance of short-term survival
21. Receiving vasopressin or its analogs for treatment of any condition
22. Known allergy to any vasopressin antagonist
23. Previous participation in a lixivaptan study
24. Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit
25. Unable to take oral medications

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average daily area under the curve (AUC) of change from baseline in serum sodium concentrations up to 72 hours in Lixivaptan treated subjects compated to placebo<br>Timepoint: 60 days

Secondary Outcome Measures

Name	Time	Method
?Average daily area under the curve (AUC) of change from Baseline in serum sodium concentrations up to Day 30 <br>?Percentage of subjects achieving normalized serum sodium (Na+ &#8805; 135 mEq/L and &#8804; 145 mEq/L)<br>?Percentage of subjects requiring fluid restriction<br>?Percentage of subjects with worsening of hyponatremia <br>?The change from baseline in the recorded time to complete the Trail Making Test, Part B (TMT ? B) at Day 30 <br>Timepoint: 60 days