Status:
COMPLETED
Post Marketing Study to Evaluate the Two Dose Regimens of Nicardipine Injection in Hypertensive Emergency Patients
Lead Sponsor:
Astellas Pharma China, Inc.
Conditions:
Hypertension Emergency
End-organ Damage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01872039
Start Date
March 1 2013
End Date
January 1 2014
Last Update
November 16 2015
Active Locations (5)
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1
Beijing, Beijing Municipality, China, 100005
2
Shijiazhuang, Hebei, China, 050000
3
Harbin, Heilongjiang, China, 150086
4
Ürümqi, Xinjiang, China, 830001