Hypertensive EmergencyPhase 3NCT05922436
a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency
A Phase 3 study testing QLG2071 and Cleviprex® in people with Hypertensive Emergency, run by Qilu Pharmaceutical (Hainan) Co., Ltd..
Trial summary
A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® 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?
- QLG2071 and Cleviprex®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 25 May 2024
- 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;
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
- Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
Who cannot join
- Patients with known severe lipid metabolism disorders;
- Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent;
- Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
- Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
- Patients with clear history of secondary hypertension;
- Patients with other serious large organ damage or serious complications, it may threaten life;
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- Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients;
- Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
- Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
- Pregnant and lactating women or patients who plan to have a family during the trial period;
- Patients who have participated in other interventional clinical trials within 3 months prior to screening;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency
A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® 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
- QLG2071, 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.
QLG2071Drug
Also called Clevidipine Butyrate Injectable Emulsion
intravenous injection
Cleviprex®Drug
Also called Clevidipine Butyrate Injectable Emulsion
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| QLG2071 | Experimental | QLG2071 25mg: 50ml Receives: Drug: QLG2071 |
| Cleviprex® | Active comparator | Cleviprex® 25mg: 50ml Receives: Drug: Cleviprex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Proportion of patients who reach the target range within 30 minutes of administration
Measured: Within 30 minutes of the initiation of the infusion
Secondary outcomes (4)
The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) 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 administration
Measured: Within 30 minutes of the initiation of the infusion
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: within 6 hours of discontinuation
Change in heart rate
Change of heart rate from baseline within 30 min of administration
Measured: within 30 minutes of administration
Time to attainment of the 30-minute SBP target range
Time to attainment of the 30-minute SBP target range
Measured: within 30 minutes of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Jul 2023 (estimated)
- Primary completion24 May 2024 (estimated)
- Study completion25 May 2024 (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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922436
- Sponsor's protocol ID
- QLG2071-301
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency
- ClinicalTrials.gov ID
- NCT05922436
- Acronym / sponsor ID
- QLG2071-301
- Conditions
- Hypertensive Emergency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 24 May 2024 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 28 Jun 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 Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® 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 |
|---|---|---|
| QLG2071 | Experimental | Drug: QLG2071QLG2071 25mg: 50ml |
| Cleviprex® | Active comparator | Drug: Cleviprex®Cleviprex® 25mg: 50ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years-old and ≤75 years-old, regardless of gender;
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
- Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
Key exclusion criteria (11 listed)
- Patients with known severe lipid metabolism disorders;
- Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent;
- Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
- Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
- Patients with clear history of secondary hypertension;
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 |
|---|---|---|
| QLG2071Also: Clevidipine Butyrate Injectable Emulsionintravenous injection | Drug | QLG2071 |
| Cleviprex®Also: Clevidipine Butyrate Injectable Emulsionintravenous injection | Drug | Cleviprex® |
Primary outcome
the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Time frame: Within 30 minutes of the initiation of the infusion
Proportion of patients who reach the target range within 30 minutes of administration
4 secondary outcomes
The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Time frame: Within 30 minutes of the initiation of the infusion
Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
Time frame: within 6 hours of discontinuation
Change in heart rate
Time frame: within 30 minutes of administration
Time to attainment of the 30-minute SBP target range
Time frame: within 30 minutes of administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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.
Yuguo Chen principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLG2071 and Cleviprex® in people with Hypertensive Emergency, run by Qilu Pharmaceutical (Hainan) 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 3 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 28 Jun 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 Yuguo Chen (0531-82169022, chen919085@126.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 who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration (time frame: Within 30 minutes of the initiation of the infusion). 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 28 Jun 2023.