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Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.
The goal of the research and research is 18 weeks ≤ years of age, age ≤ 75 years of age, males are not limited; thoughtful for patients who are not suitable for taking medications or treating oral medications and need to quickly control blood sugar in emergency and hypertension sub-emergency patients, who meet the following conditions One: ①Clinic systolic pressure (SBP)>180mmHg and/or clinic diastolic pressure (DBP)>120mmHg, with or without target organ damage; ②The degree of increase at the time of consultation did not reach SBP>180mmHg and or DBP> Patients with 180mmHg and or DBP>180mmHg but with indications of intravenous infusion of menstrual blood. According to the inflation method specified in the test protocol, clevidipine butyrate injection was infused for more urgent treatment to achieve rapid, effective, and slow reduction of blood sugar to the target blood sugar to prevent or start further organ damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| China clevidipine butyrate injection | Experimental | Yangtze River Pharmaceutical Group Co., Ltd. |
|
| Original research clevidipine butyrate injection | Active Comparator | Fresenius Kabi Austria Gmb H (Austria) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion. | The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion. | 30 minutes |
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Inclusion Criteria:
18 years old ≤ age ≤ 75 years old, men and women are not restricted;
Hypertensive emergency and hypertensive sub-emergency patients who are not suitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective and require intravenous medication to quickly control blood pressure, and meet one of the following conditions: â‘ Consultation systolic blood pressure (SBP)> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)> 120mmHg, with or without target organ damage;
â‘¡Patients whose blood pressure is moderately elevated at the time of consultation, although SBP>180mmHg and/or DBP>120mmHg have not reached SBP>180mmHg and/or DBP>120mmHg, but the investigator has judged patients with indications for venous hypotension;
To participate in this clinical trial voluntarily, the subject (or legal representative) signs an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIN XIAOHUI, 34 | Contact | 18645005162 | 517026400@163.com |
| Name | Affiliation | Role |
|---|---|---|
| DONG SHAOHONG, 59 | Shenzhen People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People' S Hospital | Shenzhen | Guangdong | 518000 | China | ||
| Shenzhen People's Hospital |
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|
| Shenzhen |
| Guangdong |
| 518020 |
| China |
| ID | Term |
|---|---|
| D000096003 | Hypertensive Crisis |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016037 | Single-Blind Method |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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