EUCTR2008-003191-21-IT进行中（未招募）不适用
``Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia`` - CK-LX3430
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). 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
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. Hyponatremia as a result of any medication that can safely be withdrawn. 7.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.
研究者
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