NCT00557661已完成1 期
A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure
Nile Therapeutics0 个研究点目标入组 20 人开始时间: 2007年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- To assess the safety and tolerability of CD-NP infusions in patients with heart failure
研究概览
简要总结
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
- •Female patients must be post-menopausal or surgically sterile
- •Diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
排除标准
- •Women who are pregnant, breast-feeding or of child-bearing potential
- •Clinically unstable patients
- •Major surgical procedures within 30 days of entry
- •Febrile temp > 100 degrees F)
- •Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
- •Currently on IV vasoactive support (e.g., heart transplant candidate)
- •History of unexplained syncope within the past 3 months
- •History of organ transplantation
- •Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.
- •Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
- •Treatment with nesiritide within 14 days prior to dosing.
- •Inability to effectively communicate with study personnel.
结局指标
主要结局
To assess the safety and tolerability of CD-NP infusions in patients with heart failure
时间窗: 28 days
次要结局
- To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion(24 hrs)
研究者
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