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

Condition(s) targeted: Hypertension Emergency; End-organ Damage

Intervention: Perdipine injection (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma China, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Inc

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients with target BP

Secondary outcome:

Blood pressure after the 6 hour treatment

The time to get target BP

Safety assessed by the incidence of adverse events, vital signs and labo tests

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Wuhan 430050, China

Beijing, Beijing 100005, China

Shijiazhuang, Hebei 050000, China

Harbin, Heilongjiang 150086, China

Urumqi, Xinjiang 830001, China

Starting date: March 2013
Last updated: June 17, 2014