EFFECTS OF VPA 985 AND PLACEBO IN TREATMENT OF HYPONATREMIA

VPA 985 和安慰剂治疗低钠血症的效果

• 批准号: 6263962
• 负责人: GARY L. ROBERTSON
• 金额: $ 2.05万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263962
• 关键词: adult human (21+); blood chemistry; body weight; clinical research; clinical trials; cognition disorders; drug administration rate /duration; hormone receptor; hormone regulation /control mechanism; human subject; human therapy evaluation; hyponatremia; inhibitor /antagonist; liver failure; plasma; sodium ion; urine; vasopressins

The objective of this study is to determine the doses of VPA-985, a selective non-peptide antagonist of vasopressin-2 receptors, that safely and efficaciously increase serum sodium in patients with hyponatremia of diverse etiologies. Secondary objectives are to compare efficacy in an outpatient and inpatient setting and to determine if correction of the hyponatremia improves congnitive function or other measures of clinical benefit. The design is a randomized, double-blind, parallel group, placebo controlled, multi-center, inpatient and outpatient study. The subjects will be patients, age 18-80, with chronic hyponatremia due to liver failure or SIADH. After pre-study screening, they will be admitted to the GCRC and randomly assigned to receive placebo or one of three doses of the VPA-985 twice daily for seven days. Fluid intake will be restricted and serum sodium, body weight, urine output, vital signs and physical condition will be determined daily. Vasopressin and other hormones will be measured before and after the treatment. If clinically indicated, the patient will be discharged on the same treatment and followed in the outpatient clinic for two weeks. The treatment then will be stopped and the final post-treatment examination given. Cognitive function tests will be performed before and after the inpatient and oupatient phase. All tests except plasma sodium will be performed or scored by a central laboratory and the results will be analyzed by Wyeth-Ayerst.

本研究的目的是确定VPA-985（一种血管加压素-2受体的选择性非肽类拮抗剂）的剂量，该剂量可安全有效地增加不同病因低钠血症患者的血清钠。 次要目的是比较门诊和住院患者的疗效，并确定低钠血症的纠正是否改善了脑功能或其他临床获益指标。 设计是一项随机、双盲、平行组、安慰剂对照、多中心、住院和门诊研究。 受试者将是年龄18-80岁的慢性低钠血症（由于肝衰竭或SIADH）患者。 在研究前筛选后，他们将被纳入GCRC，并随机分配接受安慰剂或三种剂量的VPA-985之一，每日两次，持续7天。 将限制液体摄入，并将每天测定血清钠、体重、尿量、生命体征和身体状况。 在治疗前后将测量血管加压素和其他激素。 如果有临床指征，患者将出院接受相同治疗，并在门诊随访两周。 然后停止治疗，并进行最终治疗后检查。 在住院期和门诊期前后将进行认知功能测试。 除血钠外，所有检查均由中心实验室进行或评分，并由Wyeth-Ayerst分析结果。