Trial reportJournal of clinical hypertension (Greenwich, Conn.)2025
Efficacy and Safety of a Generic Clevidipine in Hypertensive Urgencies and Non-Fulminant Hypertensive Emergencies: A Phase III, Multicenter, Randomized, Double-Blind, Positive Drug Parallel-Controlled Study.
Trial report in Journal of clinical hypertension (Greenwich, Conn.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Efficacy and Safety of a Generic Clevidipine in Hypertensive Urgencies and Non-Fulminant Hypertensive Emergencies: A Phase III, Multicenter, Randomized, Double-Blind, Positive Drug Parallel-Controlled Study.Journal of clinical hypertension (Greenwich, Conn.) · 2025Trial
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Authors and funding
33 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Hypertensive crises require rapid blood pressure control to prevent stroke and myocardial injury. Despite Cleviprex's efficacy, its high cost limits accessibility in China. This Phase III, multicenter, randomized, double-blind study evaluated the efficacy and safety of a generic clevidipine (China's first injectable generic clevidipine emulsion) versus the branded drug Cleviprex in managing hypertensive emergencies and urgencies among Chinese patients. A total of 377 patients of 33 medical centers from December 2021 to December 2022 were randomized, with 189 in the generic clevidipine group and 188 in the control. As a result, 95.6% of patients in the generic clevidipine group and 93.6% in the control achieved the target systolic blood pressure (SBP) reduction within 30 min (rate difference 0.020, 90% CI: -0.019 to 0.060). The mean area under the curve (AUC) of SBP outside the target range within the first hour was comparable between groups (329.8 ± 238.16 in generic clevidipine vs. 347.9 ± 302.79 in control). The median time to first achieve the target range within 30 min was 12.0 min in both groups. The proportion of patients successfully transitioning to oral therapy within 6 h was 93.4% in the generic clevidipine group and 93.6% in the control group. The incidence of drug-related adverse events (AEs) was reported in 50 patients (27.3%) in the generic clevidipine group and in 48 (27.9%) in the control, with no unexpected safety signals. The generic clevidipine demonstrated comparable efficacy and safety to the branded drug, supporting its potential as an effective and accessible therapeutic alternative for acute hypertension management. Trial Registration: chinadrugtrials.org.cn identifier: ChiCTR20212877.
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