Hypertensive EmergencyPhase 3NCT04670809
Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies
A Phase 3 study testing Clevidipine Butyrate Injection and Ncardipine Hydrochloride Injection in people with Hypertensive Emergency, run by Nanjing Yoko Biomedical Co., Ltd. at 2 sites in China.
Trial 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）. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertensive Emergency
- What is being tested?
- Clevidipine Butyrate Injection and Ncardipine Hydrochloride Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesChina
- Study dates
- 27 Jul 2020to Dec 2021
- 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
- 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 interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can 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. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;
- The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.
Who cannot join
- Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary 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 before entering this study;
- Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
- Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
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- Combined with other serious organ injury or serious complications which may affect the life 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 months before the trial;
- Pregnant and lactating women;
- Researchers do not consider it appropriate to participate in the clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Active, not recruiting
Beijing Anzhen Hospital，Capital Medical University
Beijing
- Recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Guo, professor, 13910039007, shubinguo@126.com
About this study
Official title: A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
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）.
- Conditions
- Hypertensive Emergency
- Being tested
- Clevidipine Butyrate Injection, Ncardipine Hydrochloride Injection
- Medical subject headings
- Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clevidipine Butyrate InjectionDrug
Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
Ncardipine Hydrochloride InjectionDrug
Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
| Study group | Role | What they receive |
|---|---|---|
| Clevidipine Butyrate Injection | Experimental | Not described Receives: Drug: Clevidipine Butyrate Injection |
| Ncardipine Hydrochloride Injection | Active comparator | Not described Receives: Drug: Ncardipine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target reaching rate within 30 min
Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.
Measured: 30 min
Secondary outcomes (2)
Mean time of target reaching
Mean time for subjects to reach target systolic blood pressure.
Measured: Procedure (whole infusion duration)
Rate of successful conversion to oral antihypertensive drugs
Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration.
Measured: 6 hours after intravenous administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start27 Jul 2020
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670809
- Sponsor's protocol ID
- NJYK-LVDP-III
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lv Q, Chen C, Lin L, Zhao X, Chen J, Liang Z, Chai Y, Du B, Sun L, Chen X, Liu M, Zhang X, Cao Z, Zhang H, Chen D, Wang Z, Zhong Y, Zhu J, Gao F, Wang X, Zhang G, Li L, Ma J, Zhao M, Ouyang Y, Guo S, Wang H, Yang P, He R, Zhao Z, Sun L, Wu L, Wu Y, Liu X, Xu T, Li N, Zhu T, Ma C. Efficacy and safety of clevidipine emulsion injection compared with nicardipine in patients with hypertensive emergencies: a randomized, single-blind, positive-parallel-controlled, phase III clinical trial. J Hypertens. 2026 Jan 1;44(1):204-210. doi: 10.1097/HJH.0000000000004180. Epub 2025 Oct 23.
PubMed 41231022
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
- ClinicalTrials.gov ID
- NCT04670809
- Acronym / sponsor ID
- NJYK-LVDP-III
- Conditions
- Hypertensive Emergency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
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）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clevidipine Butyrate Injection | Experimental | Drug: Clevidipine Butyrate Injection |
| Ncardipine Hydrochloride Injection | Active comparator | Drug: Ncardipine Hydrochloride Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:
- The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.
Key exclusion criteria (12 listed)
- Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary 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 before entering this study;
- Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
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 |
|---|---|---|
| Clevidipine Butyrate InjectionInitiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion. | Drug | Clevidipine Butyrate Injection |
| Ncardipine Hydrochloride InjectionDilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion. | Drug | Ncardipine Hydrochloride Injection |
Primary outcome
Target reaching rate within 30 min
Time frame: 30 min
Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.
2 secondary outcomes
Mean time of target reaching
Time frame: Procedure (whole infusion duration)
Rate of successful conversion to oral antihypertensive drugs
Time frame: 6 hours after intravenous administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 41231022Lv Q, Chen C, Lin L, Zhao X, Chen J, Liang Z, Chai Y, Du B, Sun L, Chen X, Liu M, Zhang X, Cao Z, Zhang H, Chen D, Wang Z, Zhong Y, Zhu J, Gao F, Wang X, Zhang G, Li L, Ma J, Zhao M, Ouyang Y, Guo S, Wang H, Yang P, He R, Zhao Z, Sun L, Wu L, Wu Y, Liu X, Xu T, Li N, Zhu T, Ma C. Efficacy and safety of clevidipine emulsion injection compared with nicardipine in patients with hypertensive emergencies: a randomized, single-blind, positive-parallel-controlled, phase III clinical trial. J Hypertens. 2026 Jan 1;44(1):204-210. doi: 10.1097/HJH.0000000000004180. Epub 2025 Oct 23.
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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.
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 testing Clevidipine Butyrate Injection and Ncardipine Hydrochloride Injection in people with Hypertensive Emergency, run by Nanjing Yoko Biomedical Co., Ltd. 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 6 inclusion and 12 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 17 Dec 2020. 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 Yiran Ge (15298359892, geyiran@yoko-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target reaching rate within 30 min (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04670809, which also lists 1 linked publication.
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 17 Dec 2020.