End-organ Damage Clinical Trial
Official title:
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment