Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia
- Conditions
- Subjects with euvolemic hyponatremiaMedDRA version: 9.1Level: LLTClassification code 10021038Term: Hyponatremia
- Registration Number
- EUCTR2006-001754-26-BE
- Lead Sponsor
- Cardiokine Biopharma, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Written informed consent
2. Men or women aged 18 or older (refer to section 12.4 of the protocol for definition of women to be included in the trial and 12.4.1 for acceptable methods of contraception)
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
5. In the investigator’s judgment, the subject 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
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. Pseudohyponatremia (i.e., hyponatremia due to a laboratory artifact)
6. Hypertonic hyponatremia (hyponatremia in the setting of hyperglycemia)
7. Hyponatremia as a result of any medication that can safely be withdrawn
8. Hyponatremia due to hypothyroidism or adrenal insufficiency
9. Current diagnosis of psychogenic polydipsia
10. Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist
11. Use of radiotherapy and/or chemotherapy within 2 wks of randomization
12. Serum creatinine >3.0 mg/dL (265.2 mol/L)
13. Uncontrolled diabetes mellitus as defined by the Investigators (e.g. HbA1c > 9%)
14. Severe pulmonary artery hypertension: subjects whose condition is expected to deteriorate
15. Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
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. Significant neurological impairment such that the subject would not be able to complete study procedures. (Examples of neurological conditions which could exclude subjets from participating, include but are not limited to Alzheimer’s disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multi-infarct dementia, mixed dementia, or Huntington’s disease)
19. Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia or non-communicative)
20. Established diagnosis of nephrotic syndrome
21. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
22. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)
23. History of chronic drug/medication abuse within the past 6 months or current alcohol abuse
24. Terminally ill or moribund condition with little chance of short-term survival
25. Receiving vasopressin or its analogs for treatment of any condition
26. Known allergy to any vasopressin antagonist
27. Previous participation in a lixivaptan study
28. Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit
29. 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
- Secondary Outcome Measures
Name Time Method