None listed
Conditions
Interventions
Lixivaptan Type of group
Lixivaptan will start at 25 mg QD and can be adjusted to optimize the patients dose according to what is described in Section 8.5. Acceptable doses are: 25 mg, 50 mg or 100 mg (two 50 mg capsules) QD. Patients who complete the trial, and those who discontinue it prematurely, will be followed for seven (7) days.
Sponsors
Cardiokine Biopharma, LLC,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Age greater than or equal to 18 years • Ability to provide informed consent or assent. • Previous participation in a hyponatremia trial with lixivaptan with evidence of desire or need to continue therapy. Patients must have demonstrated acceptable compliance with the experimental medication (> 70% of the prescribed medication taken) and adherence to the study procedures in the original trial.
Exclusion criteria
Exclusion criteria: • A current medical condition for which long-term treatment with an aquatic agent may pose an undue risk to the patient. • Hyponatremia which is acute, reversible, artificial or caused by conditions not associated with excess vasopressin or that may respond to aquatic therapy. • Hyponatremia caused by a reversible medical therapy or condition • Conditions associated with an imminent independent risk of morbidity and mortality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A local laboratory will make the evaluation of serum sodium (STAT) during the Selection visit, the visit prior to the administration of the dose (initial value) and in all visits of the Treatment Periods and after treatment, as shown in The evaluation schedule. Serum sodium will be evaluated before administering the dose during the Treatment Period. Measure:Change in initial values in serum sodium concentrations Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:(severe 135 mEq / L) at the initial value of each study visit. Measure:Percentage of patients with varying degrees of hyponatremia Timepoints:During the study ; Outcome name:If possible, the fluid restriction should not be indicated at least during the first 72 hours of administration of the experimental medication dose. The Investigator will record the initial requirements of the fluid restriction and the use of diuretics in the Reference as well as any changes related to the fluid restriction or the use of diuretics in the medical history and the eCRF in all subsequent visits. Patients will be instructed to drink freely when they are thirsty. Measure:Percentage of patients who require fluid restriction for the sole purpose of treating hyponatremia during each trial period. Evaluated descriptively at each visit. Timepoints:During the study ; Outcome name:A local laboratory will make the evaluation of serum sodium (STAT) during the Selection visit, the visit prior to the administration of the dose (initial value) and in all visits of the Treatment Periods and after treatment, as shown in The evaluation schedule. Measure:Percentage of patients who require hypertonic saline prescription for the sole purpose of treating hyponatremia during each trial period. Timepoints:During the study ; Outcome name:Body weight measurements (without shoes) will be recorded post-urination (after urinating) in kilos or pounds using the same calibrated scale, whenever possible, for each measurement. Measure:Variation of body weight at each visit (evaluated only for those with clinical evidence of hypervolemia at the initial value). Timepoints:During the study | — |
Countries
Belgium, Czech Republic, Germany, Peru
Outcome results
None listed