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

• ClinicalTrials.gov Identifier: NCT01872039
• Recruitment Status: Completed
• First Posted: June 7, 2013
• Last Update Posted: November 16, 2015
• Sponsor: Astellas Pharma China, Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma China, Inc. )

Tracking Information

• First Submitted Date: June 5, 2013
• First Posted Date: June 7, 2013
• Last Update Posted Date: November 16, 2015
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2013)

Percentage of patients with target BP [ Time Frame: After 60 minutes of the treatment ]

The target BP value is defined by investigators for every subject according to different illness state

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2013)

• Blood pressure after the 6 hour treatment [ Time Frame: At 6 hours ]
• The time to get target BP [ Time Frame: Within 2 hours after treatment ]
  The target BP value is defined by investigators for every subject according to different illness state
• Safety assessed by the incidence of adverse events, vital signs and labo tests [ Time Frame: For 6 hours ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension Emergency
• End-organ Damage

Intervention

Drug: Perdipine injection

IV

Other Name: nicardipine

Study Arms

• Active Comparator: Weight-based adjustment group
  Dosage regimen according to the current Package Insert approved by SFDA
  Intervention: Drug: Perdipine injection
• Experimental: Non-weight-based adjustment group
  Dosage regimen according to the Package Insert approved by FDA
  Intervention: Drug: Perdipine injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2014): 163
• Original Estimated Enrollment (submitted: June 5, 2013): 160
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01872039
• Other Study ID Numbers: ACN-PD-2012001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Astellas Pharma Inc ( Astellas Pharma China, Inc. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Astellas Pharma China, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Astellas Pharma Inc

• PRS Account: Astellas Pharma Inc
• Verification Date: November 2015