Post Marketing Study to Evaluate the Two Dose Regimens of Nicardipine Injection in Hypertensive Emergency Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypertension Emergency, End-organ Damage

Intervention / Treatment
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* Drug: Perdipine injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight-based adjustment group<br>Dosage regimen according to the current Package Insert approved by SFDA | Drug: Perdipine injection<br>* IV<br>* Other names: nicardipine;|
| Experimental: Non-weight-based adjustment group<br>Dosage regimen according to the Package Insert approved by FDA | Drug: Perdipine injection<br>* IV<br>* Other names: nicardipine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with target BP | The target BP value is defined by investigators for every subject according to different illness state | After 60 minutes of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure after the 6 hour treatment |  | At 6 hours | 
| The time to get target BP | The target BP value is defined by investigators for every subject according to different illness state | Within 2 hours after treatment | 
| Safety assessed by the incidence of adverse events, vital signs and labo tests |  | For 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicardipine, Hypertension, Calcium blocker