International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.
研究概览
简要总结
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
详细描述
Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years of age or older
- •Ability to provide informed consent or assent
- •Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
排除标准
- •A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
- •Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
- •Hyponatremia due to reversible medical condition or therapy
- •Conditions associated with an independent imminent risk of morbidity and mortality
结局指标
主要结局
To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.
时间窗: 28 weeks
次要结局
- To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline.(28 weeks)