None listed
Conditions
Interventions
Group 1 Type of group
Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
Group name:Group 2 Type of group
Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
Sponsors
Cardiokine Biopharma, LLC,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Written informed consent • Men or women 18 years of age or older • Diagnosis of euvolemic hyponatremia (Na <135 mEq / L). • Willing to remain under observation for approximately the first 8 hours after the start of treatment (first dose)
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding women, or women who are planning to get pregnant or breastfeed • Frank symptoms of hyponatremia that require immediate medical intervention (eg, coma, seizures) • Acute or transient hyponatremia (eg, associated with head trauma, postoperative state, or use of radiotherapy and / or chemotherapy). • Hyponatremia in hypovolemic states (eg, due to loss of fluids from vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical signs of decreased volume of extracellular fluids. • Hyponatremia in hypervolemic states (eg, congestive heart failure.) Hypervolemia is defined as the increase in total body water, with signs of edema. • Hyponatremia resulting from any medication that can be safely withdrawn. • Hyponatremia due to hypothyroidism or adrenal insufficiency. • Current diagnosis of psychogenic polydipsia. • Have received, within 7 days prior to recruitment, other medications for the treatment of hyponatremia, specifically demeclocycline, lithium carbonate, urea, or any vasopressin antagonist. • Systolic blood pressure in supine position 3.0 mg / dL (> 265.2 mol / L). • Hypokalemia, based on clinical signs / symptoms or laboratory findings (eg, serum potassium 9%. • Myocardial infarction with ST-segment elevation (STEMI) within the previous 30 days, or active myocardial ischemia at the time of recruitment. • History of stroke (CVA) within 30 days prior to selection. • Severe malnutrition, at the discretion of the Investigator (eg, body mass index [BMI] <17). • Advanced liver disease or confirmed diagnosis of cirrhosis or alcoholic hepatitis. • Urinary tract obstruction (benign prostatic hypertrophy [BPH] is admitted if it is non-obstructive). • History of chronic drug / drug abuse within the last 6 months, or alcoholism today. • Terminal disease or dying state, with little chance of short-term survival. • Be receiving vasopressin or its analogues for the treatment of any medical condition. • Known allergy to any vasopressin antagonist. • Previous participation in a lixivaptan study • Have received an investigational treatment within 30 days prior to the baseline visit. • Being unable to take medications by mouth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum sodium will be evaluated in the local laboratory (STAT) in the Selection, pre-dose (Basal), and in all visits throughout the treatment and post-treatment periods, as shown in the study schedule. Serum sodium will be evaluated before dose administration during the treatment period. Measure:Change in serum sodium to Day 7 from baseline visit Timepoints:Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum sodium will be evaluated in the local laboratory (STAT) in the Selection, pre-dose (Basal), and in all visits throughout the treatment and post-treatment periods, as shown in the study schedule. Serum sodium will be evaluated before dose administration during the treatment period. Measure:Change in the daily average of the AUC for serum sodium concentration from baseline visit to Day 28 Timepoints:Day 28 ; Outcome name:Serum sodium will be evaluated in the local laboratory (STAT) in the Selection, pre-dose (Basal), and in all visits throughout the treatment and post-treatment periods, as shown in the study schedule. Serum sodium will be evaluated before dose administration during the treatment period. Measure:Percentage of subjects who achieve a normalized serum sodium level (Na +> 135 mEq / L and 3 mEq / L in serum sodium concentrations. Measure:Percentage of subjects with worsening of hyponatremia during the double-blind period with treatment. Timepoints:during the double-blind period with treatment. ; Outcome name:Patients will be asked to complete the Trail Making Test, Part B, a motor speed test and visual attention. A complete guide for this test is provided in Annex 1. Measure:Change from the baseline visit in the time recorded until the TMT-B is completed on Day 28. Timepoints:Day 28. | — |
Countries
Belgium, Czech Republic, India, Israel, Italy, Mexico, Peru, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed