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/AClinical Study ID
NCT04670809
NJYK-LVDP-III
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 and ≤ 75, regardless of gender.
- 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;
- The legal representative and / or patient agree to participate in this clinical trialand sign an informed consent form.
Exclusion
Exclusion Criteria:
- Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acutecoronary syndrome in urgent need of surgical or emergency intervention;
- Patients with severe aortic stenosis or severe mitral stenosis;
- Patients with obstructive hypertrophic cardiomyopathy;
- Patients who have used other intravenous antihypertensive drugs within 2 hours beforeentering this study;
- 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;
- Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipidnephropathy, or acute pancreatitis with hyperlipidemia;
- Combined with other serious organ injury or serious complications which may affect thelife of the subjects;
- Patients with a history of mental illness;
- Patients with known history of alcohol / drug abuse;
- Those who have participated in other clinical trials and used test drugs 3 monthsbefore the trial;
- Pregnant and lactating women;
- 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,
ChinaSite Not Available
Beijing Chao-Yang Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
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