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

NCT ID: NCT01872039

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Hypertension Emergency; End-organ Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight-based adjustment group

Dosage regimen according to the current Package Insert approved by SFDA

Group Type: ACTIVE_COMPARATOR

Perdipine injection

Intervention Type: DRUG

IV

Non-weight-based adjustment group

Dosage regimen according to the Package Insert approved by FDA

Group Type: EXPERIMENTAL

Perdipine injection

Intervention Type: DRUG

IV

Interventions

Perdipine injection

IV

Intervention Type: DRUG

Other Intervention Names

nicardipine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Beijing, Beijing Municipality, China

Shijiazhuang, Hebei, China

Harbin, Heilongjiang, China

Ürümqi, Xinjiang, China

Wuhan, , China

Countries

China

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=ACN-PD-2012001

Link to results on Astellas Clinical Study Results Web site

Other Identifiers

ACN-PD-2012001

Identifier Type: -

Identifier Source: org_study_id