``Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia`` - CK-LX3430

• Conditions: Euvolemic hyponatremia; MedDRA version: 12.1Level: LLTClassification code 10021038Term: Hyponatremia

• Registration Number: EUCTR2008-003191-21-IT
• Lead Sponsor: CARDIOKINE BIOPHARMA, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-25
• 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). 4. Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
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. Hyponatremia as a result of any medication that can safely be withdrawn. 7. Hyponatremia due to hypothyroidism or adrenal insufficiency. 8. Current diagnosis of psychogenic polydipsia. 9. Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist. 10. Supine systolic arterial blood pressure of ≤ 90 mmHg. 11. Serum creatinine > 3.0 mg/dL (> 265.2 mol/L). 12. Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium < 3.5 mEq/L). 13. Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin glycosylated [HbA1c] > 9%). 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. Severe malnutrition in the Investigators judgment (e.g., body mass index [BMI] < 17). 17. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis. 18. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if nonobstructive). 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 within 30 days prior to baseline visit. 25. Unable to take oral medications.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.;Secondary Objective: To determine whether lixivaptan administration demonstrates improvement in serum sodium concentrations (area under the concentration-time curve [AUC]) up to Day 28 within the double-blind on-therapy period, percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L and ≤ 145 mEq/L), percentage of subjects requiring fluid restriction at any time during the treatment period, prevention of worsening hyponatremia, and the change from baseline in recorded time to complete the Trail Making Test, Part B (TMT-B) at Day 28.;Primary end point(s): Change from baseline in serum sodium on Day 7.