Hypertensive EmergencyPhase 3NCT05044364
Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency
A Phase 3 study of Hypertensive Emergency, run by Shenzhen People's Hospital at 2 sites in China.
Trial summary
Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertensive Emergency
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2021to 10 Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: ① Consultation systolic blood pressure (SBP)> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)> 120mmHg, with or without target organ damage;
- ②Patients 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.
Who cannot join
- Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more;
- Patients with severe lipid metabolism abnormalities (such as triglycerides> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia);
- Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis;
- Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or are allergic to the ingredients of study drug excipients, or are allergic to soybeans, soy products, eggs and egg products;
- Patients with known or suspected severe aortic stenosis;
- Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.);
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- Patients with known or suspected aortic dissection;
- Those with a history of drug or alcohol abuse, and those with acute hypertension caused by drug overdose;
- Pregnant or lactating women or patients who wish to have children during the trial period;
- Patients who have participated in clinical trials of other drugs or devices in the past 30 days;
- Patients who the investigator thinks are not suitable to participate in this trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shenzhen People' S Hospital
Shenzhen, Guangdong, 518000
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
About this study
Official title: A Randomized, Single-blind, Positive Drug Parallel Controlled, Multi-center Clinical Study on the Efficacy and Safety of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency
Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.
Read the detailed description
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: ① Clinic 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.
- Conditions
- Hypertensive Emergency
- Being tested
- 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.
- Medical subject headings
- Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| China clevidipine butyrate injection | Experimental | Yangtze River Pharmaceutical Group Co., Ltd. Receives: 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. |
| Original research clevidipine butyrate injection | Active comparator | Fresenius Kabi Austria Gmb H (Austria) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start11 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive EmergencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DONG SHAOHONG, 59, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044364
- Sponsor's protocol ID
- Cevidipine Butyrate Injection
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Positive Drug Parallel Controlled, Multi-center Clinical Study on the Efficacy and Safety of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency
- ClinicalTrials.gov ID
- NCT05044364
- Acronym / sponsor ID
- Cevidipine Butyrate Injection
- Conditions
- Hypertensive Emergency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 11 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.
Detailed description
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: ① Clinic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| China clevidipine butyrate injection | Experimental | 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.Yangtze River Pharmaceutical Group Co., Ltd. |
| Original research clevidipine butyrate injection | Active comparator | 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.Fresenius Kabi Austria Gmb H (Austria) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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: ① Consultation systolic blood pressure (SBP)> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)> 120mmHg, with or without target organ damage;
- ②Patients 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.
Key exclusion criteria (11 listed)
- Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more;
- Patients with severe lipid metabolism abnormalities (such as triglycerides> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia);
- Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis;
- Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or are allergic to the ingredients of study drug excipients, or are allergic to soybeans, soy products, eggs and egg products;
- Patients with known or suspected severe aortic stenosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | China clevidipine butyrate injection, Original research clevidipine butyrate injection |
Primary outcome
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.
Time frame: 30 minutes
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DONG SHAOHONG, 59 principal investigator
Shenzhen People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hypertensive Emergency, run by Shenzhen People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIN XIAOHUI, 34 (18645005162, 517026400@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.