Hypertensive EmergencyPhase 3NCT05783557
A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
A Phase 3 study testing Clevidipine Butyrate Injectable Emulsion and Cleviprex® in people with Hypertensive Emergency, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
Trial summary
A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. 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 Injectable Emulsion and Cleviprex®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Jun 2025
- 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 years-old and ≤75 years-old, regardless of gender;
- Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage;
- A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner;
- Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
Who cannot join
- Antihypertensive drugs have been used within 2 hours before the administration of test drugs;
- Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness;
- Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time;
- Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time;
- Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening;
- Patients with acute stroke within 1 month before screening;
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- Patients with clear history of secondary hypertension;
- Patients with lipid metabolism defects;
- Patients with a known history of liver failure or cirrhosis;
- Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment;
- Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products;
- Patients with mental illness, mental disorder and other disorders who cannot communicate properly;
- A history of drug abuse, drug use, or alcohol dependence;
- Female patients who are pregnant or lactating;
- Patients who have participated in other interventional clinical trials within 3 months prior to screening;
- Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Active-compared Phase Ш Clinical Trial to Evaluate Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency.
Read the detailed description
This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug.
- Conditions
- Hypertensive Emergency
- Being tested
- Clevidipine Butyrate Injectable Emulsion, Cleviprex®
- 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 Injectable EmulsionDrug
Also called HC1902
intravenous injection
Cleviprex®Drug
Also called Clevidipine Butyrate Injectable Emulsion
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group Receives: Drug: Clevidipine Butyrate Injectable Emulsion |
| Active-compared Group | Active comparator | Active-compared Group Receives: Drug: Cleviprex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Measured: 30 minutes
Secondary outcomes (6)
The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of within 30 minutes of administration
The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of within 30 minutes of administration
Measured: 30 minutes
AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
Measured: 1 hour
Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
Measured: 6 hours
Change of heart rate from baseline within 30 min of administration
Change of heart rate from baseline within 30 min of administration
Measured: 30 minutes
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Measured: Throughout the study period, within 72 hours
Total dosage of clevidipine butyrate injectable emulsion
Total dosage of clevidipine butyrate injectable emulsion
Measured: Throughout the study period, within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (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.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Principal investigator, Beijing Anzhen Hosipital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783557
- Sponsor's protocol ID
- HC1902-002
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-compared Phase Ш Clinical Trial to Evaluate Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
- ClinicalTrials.gov ID
- NCT05783557
- Acronym / sponsor ID
- HC1902-002
- Conditions
- Hypertensive Emergency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Mar 2023 (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.
A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency.
Detailed description
This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Clevidipine Butyrate Injectable EmulsionExperimental Group |
| Active-compared Group | Active comparator | Drug: Cleviprex®Active-compared Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years-old and ≤75 years-old, regardless of gender;
- Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage;
- A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner;
- Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
Key exclusion criteria (16 listed)
- Antihypertensive drugs have been used within 2 hours before the administration of test drugs;
- Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness;
- Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time;
- Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time;
- Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening;
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 Injectable EmulsionAlso: HC1902intravenous injection | Drug | Experimental Group |
| Cleviprex®Also: Clevidipine Butyrate Injectable Emulsionintravenous injection | Drug | Active-compared Group |
Primary outcome
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Time frame: 30 minutes
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
6 secondary outcomes
The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of within 30 minutes of administration
Time frame: 30 minutes
AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
Time frame: 1 hour
Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
Time frame: 6 hours
Change of heart rate from baseline within 30 min of administration
Time frame: 30 minutes
Incidence of adverse events (AEs)
Time frame: Throughout the study period, within 72 hours
Total dosage of clevidipine butyrate injectable emulsion
Time frame: Throughout the study period, within 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Changsheng Ma principal investigator
Beijing Anzhen Hosipital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clevidipine Butyrate Injectable Emulsion and Cleviprex® in people with Hypertensive Emergency, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
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 16 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@mail.cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration (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 24 Mar 2023.