Evaluation of the Effect of Ultrashort-Acting Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 14
- 主要终点
- Percentage of patients in whom SBP falls below the lower limit of the patient-specific, pre-determined blood pressure target range at the initial dose (2.0 mg/h)
研究概览
简要总结
The purpose of this study was to determine the safety of clevidipine for treating severely elevated blood pressure, defined as systolic (SBP) >180 mmHg and/or diastolic blood pressure (DBP) >115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients with or without major organ injury, particularly with respect to controlled dose adjustment to desired effect and prolonged continuous infusion. Enrollment of patients into the study was to continue until the target goal of 100 patients with at least 18 hours of continuous clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ injury, was met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age 18 years or older
- •Systolic blood pressure >180 mmHg and/or diastolic blood pressure >115 mmHg assessed on two successive occasions, 15 minutes apart at baseline
- •Written informed consent
排除标准
- •SBP ≤180 mmHg and/or DBP ≤115 mmHg
- •Expectation that the patient will not tolerate intravenous antihypertensive therapy for at least 18 hours
- •Known or suspected aortic dissection
- •Administration of an agent for treating hypertension within 2 hours of clevidipine administration
- •Severe hypertension known to be precipitated by use of, or withdrawal from, alcohol or illicit drugs, or intentional overdose of illicit or prescription drugs
- •Positive pregnancy test
- •Intolerance to calcium channel blockers
- •Allergy to soybean oil or egg lecithin
- •Known liver failure or cirrhosis
- •Participation in clinical research studies of other investigational drugs or devices within 30 days of enrollment
研究组 & 干预措施
clevidipine
A patient-specific blood pressure target range (TR) of ≥20 mm Hg and ≤40 mm Hg SBP was prespecified by the investigator. Once established, clevidipine (0.5 mg/mL in 20% lipid emulsion) intravenous infusion was initiated at 2.0 mg/h and maintained for the first 3 minutes. Clevidipine was up-titrated, as tolerated by the patient, by doubling the dose every 3 minutes until the prespecified systolic blood pressure (SBP) target range was achieved and could continue to be titrated up or down to maintain the desired long-term SBP reduction.
干预措施: clevidipine (Drug)
结局指标
主要结局
Percentage of patients in whom SBP falls below the lower limit of the patient-specific, pre-determined blood pressure target range at the initial dose (2.0 mg/h)
时间窗: Study drug initiation through the first 3 minutes of the infusion
Percentage of patients who reach the prespecified target SBP range
时间窗: Within 30 minutes of the initiation of the infusion
次要结局
- Time to attainment of the 30-minute SBP target range(During the 30-minute period from initiation of infusion)
- Change in heart rate(During the 30-minute period from initiation of infusion)
- Mean and median dose of clevidipine during the treatment period(Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours))
- Proportion of patients transitioning to oral antihypertensive therapy(Within 6 hours of stopping study drug infusion)
- Safety of clevidipine infusion for 18 hours or longer(Treatment period is from initiation of infusion until study drug termination (minimum of 18 hours up to a maximum of 96 hours))