A Phase IV, Randomized Trial to Determine the Efficacy and Safety of Cardene Intravenous (I.V.) Versus Labetalol for Management of Hypertensive Emergencies in the Emergency Department Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.
详细描述
More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality.
Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.
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
- 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
- •18 years of age or older
- •Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)
排除标准
- •Use of any investigational drug within 1 month prior to emergency department (ED)
- •Pregnant or breast-feeding females
- •Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)
- •Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) <35%
- •History of stroke within 30 days
- •Known liver failure
- •Suspected myocardial infarction
- •Suspected aortic dissection
- •Suspected cocaine overdose
- •Concurrently receiving other intravenous (I.V.) hypertensive medications
研究组 & 干预措施
1
nicardipine intravenous
干预措施: nicardipine intravenous (Drug)
2
Labetalol
干预措施: Labetalol (Drug)
结局指标
主要结局
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.
时间窗: 30 minutes after initiation of therapy
Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.
次要结局
- Average Number of Dose Titrations Within 30 Minutes(30 minutes)
- Emergency Department(ED)Time to Disposition Decision(6 hours)
- Treatment Failure(6 hours)
- Transition Time to Oral Medication(6 hours)
- Subjects Requiring the Use of Intravenous Rescue Medications(6 hours)