A Multi-center, Randomized and Controlled Phase IV Study on the Efficacy and Safety of Two Dose Adjustment Regimens of Nicardipine Injection for Hypertensive Emergency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 163
- 主要终点
- Percentage of patients with target BP
研究概览
简要总结
To compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and non-weight-based) for the treatment of Chinese hypertensive emergency patients.
详细描述
This study is a prospective, multi-center, open-label, randomized and controlled study. Subjects are selected from hypertensive emergency patients with a BP (Blood Pressure) of >180/120mmHg (SBP/DBP) and accompany with end target organ damage. All subjects are randomized into two groups receiving the Nicardipine Injection: Control Group (at a weight-based dose adjustment, i.e. according to the current Package Insert approved by SFDA) and Study Group (at a non-weight-based dose adjustment, i.e. according to the Package Insert approved by FDA).
Patients meet the inclusion/exclusion criteria are randomly allocated at 1:1 proportion to Control Group and Study Group. Before the treatment, investigators should define the target BP value for every subject according to different illness state, According to the BP, the dose of Nicardipine Injection is adjusted through different methods until reaching of target BP value. After reaching target BP value or 60min after the dosing initiation, BP and pulse rate are measured every 5~15min for 2h. Two to six hours after dosing, BP should be controlled at 160/100~110mmHg, and the maintenance dose is determined by the investigators according to the illness state.
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
- •Systolic blood pressure (SBP) ≥180mmHg and/or diastolic blood pressure (DBP) ≥120mmHg, and with the evidences or manifestations of end-organ damage (i.e. with any following hypertension emergency symptom: Chest pain, short breath, upper abdominal discomfort, syncope, vertigo, blurred vision, consciousness, hematuria or ischemic change under 12-lead ECG)
- •Able to and voluntary to complete this study according to this study protocol, and sign the Informed Consent Form by himself/herself (or via his/her legal guardian)
排除标准
- •Allergy to the Nicardipine Injection or its compositions
- •Serious aortic valve stenosis
- •Peri-operative hypertension
- •Cerebral hemorrhage caused by the cerebrovascular malformation, hemangioma or cerebral infarction, cerebral hemorrhage into cerebral ventricle, and cerebral trauma with concomitant cerebral hemorrhage
- •Other possible influencing factors for the safety or efficacy judgment in the investigators' opinions
研究组 & 干预措施
Weight-based adjustment group
Dosage regimen according to the current Package Insert approved by SFDA
干预措施: Perdipine injection (Drug)
Non-weight-based adjustment group
Dosage regimen according to the Package Insert approved by FDA
干预措施: Perdipine injection (Drug)
结局指标
主要结局
Percentage of patients with target BP
时间窗: After 60 minutes of the treatment
The target BP value is defined by investigators for every subject according to different illness state
次要结局
- Blood pressure after the 6 hour treatment(At 6 hours)
- The time to get target BP(Within 2 hours after treatment)
- Safety assessed by the incidence of adverse events, vital signs and labo tests(For 6 hours)