EUCTR2008-003191-21-DE进行中（未招募）不适用
Multicenter, Randomized, Double-blind, Placebo-controlledStudy to Evaluate the Safety and Tolerability of OralLixivaptan Capsules in Subjects with EuvolemicHyponatremia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 Hyponatremia as a result of any medication that can safely be withdrawn.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 study 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, multi-infarct 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).
研究者
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