NCT00839007已完成2 期
A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
Nile Therapeutics0 个研究点目标入组 77 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for acute decompensated heart failure.
- •Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
- •Renally compromised.
- •Female patients must be post-menopausal or surgically sterile.
排除标准
- •Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
- •Cardiogenic shock
- •Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
- •Clinically significant aortic or mitral valve stenosis
- •Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
- •ADHF due to significant arrhythmias
- •Severe renal failure defined as creatinine clearance < 30 mL/min
- •Current or planned ultrafiltration, hemofiltration, or dialysis
- •Significant pulmonary disease
- •Major neurologic event, including cerebrovascular events in the prior 60 days.
- •Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
- •Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
研究组 & 干预措施
A
Experimental
Dose 1 of CD-NP
干预措施: CD-NP (Drug)
B
Experimental
Dose 2 of CD-NP
干预措施: CD-NP (Drug)
C
Experimental
Dose 3 of CD-NP
干预措施: CD-NP (Drug)
D
Experimental
Dose 4 of CD-NP
干预措施: CD-NP (Drug)
E
Experimental
Dose 5 of CD-NP
干预措施: CD-NP (Drug)
F
Experimental
Dose 6 of CD-NP
干预措施: CD-NP (Drug)
G
Placebo Comparator
Placebo
干预措施: CD-NP (Drug)
结局指标
主要结局
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
时间窗: Up to 72 hours
次要结局
未报告次要终点
研究者
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