PER-112-09已完成未知
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
入选标准
- •Written informed consent
- •Men or women 18 years of age or older
- •Diagnosis of euvolemic hyponatremia (Na <135 mEq / L).
- •Willing to remain under observation for approximately the first 8 hours after the start of treatment (first dose)
排除标准
- •Pregnant or breastfeeding women, or women who are planning to get pregnant or breastfeed
- •Frank symptoms of hyponatremia that require immediate medical intervention (eg, coma, seizures)
- •Acute or transient hyponatremia (eg, associated with head trauma, postoperative state, or use of radiotherapy and / or chemotherapy).
- •Hyponatremia in hypovolemic states (eg, due to loss of fluids from vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical signs of decreased volume of extracellular fluids.
- •Hyponatremia in hypervolemic states (eg, congestive heart failure.) Hypervolemia is defined as the increase in total body water, with signs of edema.
- •Hyponatremia resulting from any medication that can be safely withdrawn.
- •Hyponatremia due to hypothyroidism or adrenal insufficiency.
- •Current diagnosis of psychogenic polydipsia.
- •Have received, within 7 days prior to recruitment, other medications for the treatment of hyponatremia, specifically demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
- •Systolic blood pressure in supine position <90 millimeters of mercury (mmHg).
- •Serum creatinine> 3.0 mg / dL (> 265.2 mol / L).
- •Hypokalemia, based on clinical signs / symptoms or laboratory findings (eg, serum potassium <3.5 mEq / L).
- •Uncontrolled diabetes mellitus at the discretion of the Researcher (eg, glycosylated hemoglobin [HbA1c]> 9%.
- •Myocardial infarction with ST-segment elevation (STEMI) within the previous 30 days, or active myocardial ischemia at the time of recruitment.
- •History of stroke (CVA) within 30 days prior to selection.
- •Severe malnutrition, at the discretion of the Investigator (eg, body mass index [BMI] <17).
- •Advanced liver disease or confirmed diagnosis of cirrhosis or alcoholic hepatitis.
- •Urinary tract obstruction (benign prostatic hypertrophy [BPH] is admitted if it is non-obstructive).
- •History of chronic drug / drug abuse within the last 6 months, or alcoholism today.
- •Terminal disease or dying state, with little chance of short-term survival.
- •Be receiving vasopressin or its analogues for the treatment of any medical condition.
- •Known allergy to any vasopressin antagonist.
- •Previous participation in a lixivaptan study
- •Have received an investigational treatment within 30 days prior to the baseline visit.
- •Being unable to take medications by mouth.
研究者
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