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Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency

NCT05044364 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-09-14

No results posted yet for this study

Summary

Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.

Conditions

  • Hypertensive Emergency

Interventions

DRUG

This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test.

Patients with hypertensive emergency and hypertensive sub-emergency who are clinically diagnosed as unsuitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective, and require intravenous medication to quickly control their blood pressure. The qualified subjects will be randomly divided into groups according to the test protocol. The method of administration is to infuse clevidipine butyrate injection for emergency blood pressure reduction treatment to achieve rapid, effective and stable lowering of blood pressure to the target blood pressure, and prevent or reduce further damage to the target organ.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • DONG SHAOHONG, 59 · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-04-01
Completion
2022-10-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05044364 on ClinicalTrials.gov