A Phase 3 interventional study of QLG2071 and Cleviprex® in Hypertensive Emergency, sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd. (part of Qilu Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment
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
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
31 studies on the registry are indexed under Hypertensive Crisis; 9 are open to participants now.
This study's planned enrollment of 378 is above the median of 140 across 19 interventional studies indexed under Hypertensive Crisis.
Browse Hypertensive Crisis studies →Qilu Pharmaceutical (Hainan) Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QLG2071 25mg: 50ml
Drug: QLG2071
Cleviprex® 25mg: 50ml
Drug: Cleviprex®
intravenous injection
Also known as: Clevidipine Butyrate Injectable Emulsion
intravenous injection
Also known as: Clevidipine Butyrate Injectable Emulsion
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
Time frame: 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
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
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
Change of heart rate from baseline within 30 min of administration
Time frame: 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
Time frame: within 30 minutes of administration
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Time frame: Throughout the study period,up to 4 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clevidipine
Qilu Pharmaceutical (Hainan) Co., Ltd. →