EUCTR2004-005239-25-ES进行中（未招募）1 期
An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety
Sanofi-Synthelabo Research0 个研究点开始时间: 2006年4月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Male or female patients aged 18 years and higher
- •Serum sodium between 115 mmol/L and 132 mmol/L
- •Urinary osmolality > 200 mOsm/kg H2O
- •Urinary sodium > 30 mmol/L
- •Ability to give written informed consent (the informed consent form should be signed by a legally authorized representative if the patient is unable to sign).
- •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
- •Patients with acute post operative SIADH
- •Presence of dilutional hyponatremia in hypervolemic states (CHF and liver disease with Ascites)
- •Presence of sign of hypovolemia
- •Administration of other V2 receptor antogonists or demeclocycline or lithium within one month, thiazide diuretics or spironolactone within 15 days and urea or loop diuretics within 2 days prior to study drug administration.
- •Presence of untreated hypothyroidisme or adrenal deficiency
- •Presence of uncontrolled diabetes with fasting glycemia > or equal to 200 mg/dL (> or equal 11.09 mmol/L)
- •Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John’s Wort) or potent and specific moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
- •Inadequate hematological, renal and hepatic functions
- •Positive pregnancy test and absence of medically approved contraceptive methods for female of childbearing potential
- •Pregnancy or breast-feading
研究者
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