NCT01872039

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Perdipine injection	IV

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-06-07
• Last updated: 2015-11-16

Locations

5 sites across 1 country: China