CTRI/2009/091/000400已完成3 期
Efficacy and Safety of Intravenous Administration of Conivaptan Hydrochloride in the Treatment of Euvolemic and Hypervolemic Hyponatremia - A multicentric, open label, non comparative, phase III study
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, aged more than or equal to 18 years.
- •2.Patients who have mean serum sodium concentration between 115 and 129 mEq per liter both inclusive.
- •3.Patients who have serum osmolality less 290 mOsmol per kg water.
- •Mean serum sodium concentration refers to the mean of two serum sodium readings 0 and 4 hours obtained during the baseline period of 4 to 12 hours. For the patients in whom treatment of hyponatremia with conivaptan cannot be delayed, the sample at 0 hr will be considered as the baseline reading.
- •Note: Patients of either sex, aged more than or equal to 18 years
排除标准
- •1.Patients unwilling or unable to give informed consent.
- •2.Random blood glucose more than or equal to 300 mg per dl.
- •3.Urinary sodium less tha 30mEq per liter with normal dietary salt intake.
- •4.Patients expected to have hyponatremia necessitating emergent treatment during the study.
- •5.Patients diagnosed with hypovolemic hyponatremia.
- •6.Patients diagnosed with congestive heart failure CHF NYHA class IV or Cirrhosis
- •7.Pregnant or lactating women or women in reproductive age group not using reliable contraception i.e. a medically accepted effective method of birth control
- •8.Patients with cardiac surgery, myocardial infarction, unstable angina or cerebrovascular accident in the past 3 months.
- •9.Patients with uncontrolled hypertension or supine systolic blood pressure less than 85 mmHg.
- •10.Patients with uncontrolled arrhythmias
- •11.Patients with creatinine clearance less than or equal to 30 ml per min per 1.73 m2.
- •12.Patients with urinary outflow obstruction unless catheterized.
- •13.Patients with abnormal laboratory values at admission into the study: SGOT or SGPT more than 3 times the upper limit of normal or serum albumin less than or equal to 1.5 g/dl.
- •14.Prothrombin time greater than 22 sec or an international normalized ratio greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy.
- •15.Patients taking CYP3A4 inhibitors or substrates such as ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, calcium channel blockers, digoxin or digitoxin, statins, benzodiazepines, vasopressin, oxytocin, desmopressin, carbamazepine, lithium, demeclocycline and urea.
- •16.Patients in whom another investigational drug defined as not approved for any indication by the local regulatory agency was used within 30 days of screening
- •17.Patients with any concurrent illness that could interfere with study treatment or its evaluation.
研究者
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