Multicenter, Randomized, Double-blind, Placebo-controlledStudy to Evaluate the Safety and Tolerability of OralLixivaptan Capsules in Subjects with EuvolemicHyponatremia

• Conditions: Euvolemic hyponatremia; MedDRA version: 9.1Level: LLTClassification code 10021038Term: Hyponatremia

• Registration Number: EUCTR2008-003191-21-CZ
• Lead Sponsor: Cardiokine Biopharma, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Written informed consent.
2. Men or women aged 18 or older.
3. Diagnosis of euvolemic hyponatremia (Na+< 135 mEq/L). Repeat measures of
serum sodium are allowed; the last serum sodium result within 24 hours prior to
randomization will serve as the qualifying measurement.
4. Willing to be observed in a monitored setting for approximately the first 8 hours
following treatment initiation.
5. In the Investigator’s judgment the patient has adequate visual and auditory acuity to allow participation in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.,
coma, seizures).
3. Acute or transient hyponatremia (e.g., associated with head trauma, postoperative
state, or use of radiotherapy and/or chemotherapy).
4. Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting,
diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of
clinical evidence of extracellular fluid volume depletion.
5. Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
6. Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
7. Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia).
8. Hyponatremia as a result of any medication that can safely be withdrawn.
9. Hyponatremia due to hypothyroidism or adrenal insufficiency.
10. Current diagnosis of psychogenic polydipsia.
11. Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
12. Supine systolic arterial blood pressure of = 90 millimeters of mercury (mmHg).
13. Serum creatinine > 3.0 mg/dL (> 265.2 mol/L).
14. Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium < 3.5 mEq/L).
15. Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin – glycosylated [HbA1c] > 9%).
16. ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment.
17. History of cerebral vascular accident (CVA) within 30 days prior to screening.
18. Severe malnutrition in the Investigator’s judgment (e.g., body mass index [BMI] < 17).
19. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis.
20. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive).
21. History of chronic drug/medication abuse within the past 6 months or current alcohol abuse.
22. Terminally ill or moribund condition with little chance of short-term survival.
23. Receiving vasopressin or its analogs for treatment of any condition.
24. Known allergy to any vasopressin antagonist.
25. Previous participation in a lixivaptan study.
26. Recipient of any investigational treatment within 30 days prior to baseline visit.
27. Unable to take oral medications.
28. Significant neurological impairment such that the subject would not be able to
complete the procedures. (Examples of neurological conditions which could
exclude subject from participating, include but are not limited to Alzheimer’s
disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multiinfarct
dementia, mixed dementia, or Huntington’s disease).
29. Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia, or non-communicative).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified