CTRI/2011/04/001694已完成3 期
An open label, multicentric study to assess the efficacy and safety of Conivaptan hydrochloride injections in patients suffering from euvolemic or hypervolemic hyponatremia - None
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
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
入选标准
- •1.Patients of either sex more than or equal to 18 years of age.
- •2.Patients with established diagnosis of euvolemic or hypervolemic hyponatremia with serum sodium levels less than or equal to 130 mEq/L.
- •3.Informed consent of the patient / relative.
排除标准
- •1.Pregnancy and/or Lactation.
- •2.Patients with significant orthostatic hypotension or supine systolic blood pressure less than 90 mm of Hg.
- •3.Patients with uncontrolled hypertension, cardiac arrhythmias or diabetes mellitus.
- •4.Patients with moderate to severe hepatic and /or renal dysfunction.
- •5.Patients with known hypersensitivity to Conivaptan hydrochloride or any of the components of the study medication.
- •6.Patients with any other serious concurrent illness or malignancy.
- •7.Patients with continuing history of alcohol and / or drug abuse.
- •8.Participation in another clinical trial in the past 3 months.
研究者
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