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. )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension Emergency; End-organ Damage	Drug: Perdipine injection	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Weight-based adjustment group; Dosage regimen according to the current Package Insert approved by SFDA	Drug: Perdipine injection; IV; Other Name: nicardipine
Experimental: Non-weight-based adjustment group; Dosage regimen according to the Package Insert approved by FDA	Drug: Perdipine injection; IV; Other Name: nicardipine

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Blood pressure after the 6 hour treatment [ Time Frame: At 6 hours ]
2. 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
3. Safety assessed by the incidence of adverse events, vital signs and labo tests [ Time Frame: For 6 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Beijing

Beijing, Beijing, China, 100005

China, Hebei

Shijiazhuang, Hebei, China, 050000

China, Heilongjiang

Harbin, Heilongjiang, China, 150086

China, Xinjiang

Urumqi, Xinjiang, China, 830001

China

Wuhan, China, 430050

Sponsors and Collaborators

Astellas Pharma China, Inc.

Investigators

• Study Director: Medical Director; Astellas Pharma Inc

More Information

Additional Information:

Link to results on Astellas Clinical Study Results Web site 

• Responsible Party: Astellas Pharma China, Inc.
• ClinicalTrials.gov Identifier: NCT01872039
• Other Study ID Numbers: ACN-PD-2012001
• First Posted: June 7, 2013
• Last Update Posted: November 16, 2015
• Last Verified: November 2015

Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):

Nicardipine; Hypertension; Calcium blocker

Additional relevant MeSH terms:

Hypertension; Emergencies; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Nicardipine; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents