Hypertensive Emergency
Conditions
Brief 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
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
Interventions
DRUGQLG2071
intravenous injection
DRUGCleviprex®
intravenous injection
Sponsors
Qilu Pharmaceutical (Hainan) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years-old and ≤75 years-old, regardless of gender; 2. Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg assessed on two successive occasions, 15 minutes apart at baseline； 3. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
Exclusion criteria
1. Patients with known severe lipid metabolism disorders; 2. 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; 3. Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent; 4. Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment; 5. Patients with clear history of secondary hypertension; 6. Patients with other serious large organ damage or serious complications, it may threaten life; 7. 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; 8. Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs; 9. Patients who cannot tolerate intravenous infusion therapy for at least 6 hours; 10. Pregnant and lactating women or patients who plan to have a family during the trial period; 11. Patients who have participated in other interventional clinical trials within 3 months prior to screening;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration | Within 30 minutes of the initiation of the infusion | Proportion of patients who reach the target range within 30 minutes of administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration | Within 30 minutes of the initiation of the infusion | The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration |
| Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation | within 6 hours of discontinuation | Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation |
| Change in heart rate | within 30 minutes of administration | Change of heart rate from baseline within 30 min of administration |
| Time to attainment of the 30-minute SBP target range | within 30 minutes of administration | Time to attainment of the 30-minute SBP target range |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Throughout the study period,up to 4 days | Incidence of adverse events (AEs) |
Contacts
Primary ContactYuguo Chen
Outcome results
None listed