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

NCT01872039 | Completed Phase 4

• 1 other identifier: ACN-PD-2012001
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypertension Emergency; End-organ Damage

Keywords

Nicardipine; Hypertension; Calcium blocker

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with target BP

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

  After 60 minutes of the treatment

Secondary Outcomes (3)

• Blood pressure after the 6 hour treatment

  At 6 hours

• The time to get target BP

  Within 2 hours after treatment

• Safety assessed by the incidence of adverse events, vital signs and labo tests

  For 6 hours

Study Arms (2)

Weight-based adjustment group

ACTIVE COMPARATOR

Dosage regimen according to the current Package Insert approved by SFDA

Drug: Perdipine injection

Non-weight-based adjustment group

EXPERIMENTAL

Dosage regimen according to the Package Insert approved by FDA

Drug: Perdipine injection

Interventions

Perdipine injection DRUG

IV

Also known as: nicardipine

Non-weight-based adjustment group; Weight-based adjustment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (5)

Unknown Facility

Beijing, Beijing Municipality, 100005, China

Location

Unknown Facility

Shijiazhuang, Hebei, 050000, China

Location

Unknown Facility

Harbin, Heilongjiang, 150086, China

Location

Unknown Facility

Ürümqi, Xinjiang, 830001, China

Location

Unknown Facility

Wuhan, 430050, China

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Hypertension

Interventions

Nicardipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

CN (5)