Clinical trial NCT01872039: Post Marketing Study to Evaluate the Two Dose Regimens of Nicardipine Injection in Hypertensive Emergency Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension Emergency
End-organ Damage
Keywords: Nicardipine
Hypertension
Calcium blocker
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with target BP
timeFrame: After 60 minutes of the treatment
Secondary outcomes:
measure: Blood pressure after the 6 hour treatment
timeFrame: At 6 hours
measure: The time to get target BP
timeFrame: Within 2 hours after treatment
measure: Safety assessed by the incidence of adverse events, vital signs and labo tests
timeFrame: For 6 hours
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Shijiazhuang
country: China
state: Hebei
city: Harbin
country: China
state: Heilongjiang
city: Urumqi
country: China
state: Xinjiang
city: Wuhan
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: