Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Last updated: December 15, 2020
Sponsor: Nanjing Yoko Biomedical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

High Blood Pressure (Hypertension - Pediatric)

High Blood Pressure (Hypertension)

Treatment

N/A

Clinical Study ID

NCT04670809
NJYK-LVDP-III
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies(defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg, accompanied by acute organ damage).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75, regardless of gender.
  2. Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an intervalof 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied withprogressive target organ damages as below or evidences of other target organ damagecan be confirmed:
  • Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting,blurred vision and other symptoms;
  • Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
  • Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patientswith SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensiveemergency;
  1. The legal representative and / or patient agree to participate in this clinical trialand sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acutecoronary syndrome in urgent need of surgical or emergency intervention;
  2. Patients with severe aortic stenosis or severe mitral stenosis;
  3. Patients with obstructive hypertrophic cardiomyopathy;
  4. Patients who have used other intravenous antihypertensive drugs within 2 hours beforeentering this study;
  5. Patients known to be intolerant or allergic to calcium channel blockers, or allergicto test drug ingredients, or allergic to soy / soy products or egg / egg products;
  6. Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipidnephropathy, or acute pancreatitis with hyperlipidemia;
  7. Combined with other serious organ injury or serious complications which may affect thelife of the subjects;
  8. Patients with a history of mental illness;
  9. Patients with known history of alcohol / drug abuse;
  10. Those who have participated in other clinical trials and used test drugs 3 monthsbefore the trial;
  11. Pregnant and lactating women;
  12. Researchers do not consider it appropriate to participate in the clinical trial.

Study Design

Total Participants: 262
Study Start date:
July 27, 2020
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

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