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

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

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.


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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872039


Locations
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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
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT01872039     History of Changes
Other Study ID Numbers: ACN-PD-2012001
First Posted: June 7, 2013    Key Record Dates
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:
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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