NCT00739193撤回2 期
A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Men and women >18 years of age at Screening, with a diagnosis of stable congestive heart failure
- •NYHA Functional Classification of Heart Failure Class II, III, or IV
- •Documented left ventricular ejection fraction ≤35% within 6 months before Screening, provided that the assessment was not within 4 weeks of a myocardial infarction
- •Outpatient or inpatient
- •On stable doses of medications to treat congestive heart failure (eg, beta-blockers, angiotensin-converting enzyme inhibitor/angiotensin-receptor antagonist, diuretic) for at least 7 days before dosing with trial drug
- •Have a 12-lead electrocardiogram (ECG) at Screening that shows no clinically significant abnormalities of rate, rhythm, or conduction (such as high-grade atrioventricular block, bifascicular or trifascicular block), that would jeopardize the safety or the ability to accurately measure the arterial pressure of the subject, in the opinion of the investigator
- •Able to communicate effectively with the trial personnel
- •Able to undergo study related procedures as required by the protocol
- •Adequately informed of the nature and risks of the trial and give written informed consent prior to undergoing any trial-related procedures
- •Women of childbearing potential must have a negative pregnancy test both at Screening and at check-in to the trial site before receiving trial drug on Day 1 and must be using an effective medically acceptable form of birth control for the duration of the trial (up through the Day 8 follow-up evaluation)
排除标准
- •Known hypersensitivity or allergy to amiodarone, Captisol, Amiodarone IV, or any of its excipients
- •Known hypersensitivity or allergy to iodine or radio-opaque dyes
- •Presence of asthma or other pulmonary disease, thyroid disease (hypo or hyperthyroidism), hepatitis, or other liver disease that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- •Myocardial infarction within the 30 days before Screening
- •Functioning pacemaker at Screening or on Day 1
- •Amiodarone administration within 7 days before dosing with trial drug
- •Cardiogenic shock, marked sinus bradycardia, or second- or third-degree atrioventricular block
- •Any disease or condition that might compromise trial evaluations or place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- •Any clinically significantly abnormal laboratory test at Screening or Day 1 that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- •Women who are pregnant or breastfeeding A-ny subject who has received an investigational drug within 30 days before dosing with trial drug
- •Inability to obtain 3 baseline SAP readings with no more than 5 mm Hg difference among these readings
研究组 & 干预措施
Amiodarone IV
Active Comparator
Amiodarone IV
干预措施: amiodarone (Drug)
Placebo
Placebo Comparator
Placebo Control
干预措施: amiodarone (Drug)
PM101
Experimental
PM101
干预措施: amiodarone (Drug)
结局指标
主要结局
Systolic blood pressure
时间窗: 15 minutes
次要结局
未报告次要终点
研究者
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