EUCTR2008-003191-21-CZ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 Hyponatremia as a result of any medication that can safely be withdrawn.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 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).
研究者
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