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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872039
• Other study ID #: ACN-PD-2012001
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2013
• Last updated: November 13, 2015
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Emergencies
• End-organ Damage
• Hypertension Emergency

Intervention

Drug:
• Perdipine injection
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with target BP	The target BP value is defined by investigators for every subject according to different illness state	After 60 minutes of the treatment	No
Secondary	Blood pressure after the 6 hour treatment		At 6 hours	No
Secondary	The time to get target BP	The target BP value is defined by investigators for every subject according to different illness state	Within 2 hours after treatment	No
Secondary	Safety assessed by the incidence of adverse events, vital signs and labo tests		For 6 hours	No

External Links

•   Link to results on Astellas Clinical Study Results Web site