End-organ Damage, Hypertension Emergency
Conditions
Keywords
Nicardipine, Hypertension, Calcium blocker
Brief summary
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
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.
Interventions
DRUGPerdipine injection
IV
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with target BP | After 60 minutes of the treatment | The target BP value is defined by investigators for every subject according to different illness state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure after the 6 hour treatment | At 6 hours | — |
| The time to get target BP | Within 2 hours after treatment | The target BP value is defined by investigators for every subject according to different illness state |
| Safety assessed by the incidence of adverse events, vital signs and labo tests | For 6 hours | — |
Countries
China
Outcome results
None listed