Journal Article

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

Li, Shugui, Chen, Dexiong, Shi, Zhiming, Sheng, Jianlong, Zhang, Xiwen, Mo, Qiuping, Hong, Lang, Ma, Wei, Guo, Dongna, Liang, Zijing, Guo, Wei, Guo, Xiaomei, Han, Xiaoning, Chai, Yanfen, Tang, Lizhen, Zhang, Ningru, Yang, Lishan, Bin, Wenkai, Wang, Yu, Chen, Anbao, Wan, Xiaoqun, Lin, Ling, Zhu, Baofeng, Zhu, Jiaying, Cheng, Dapeng, Wang, Guangjun, Wang, Bo, Zheng, Chunhua, Lian, Qiufang, Zhu, Zhenzhong, Yu, Anyong, Huo, Yong, Gu, Xiang

2025

Overview

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.

• Publisher: John Wiley & Sons, Inc,Wiley
• Subject: Adult / Aged / Antihypertensive Agents - administration & dosage / Antihypertensive Agents - adverse effects / Antihypertensive Agents - therapeutic use / Blood pressure / Blood Pressure - drug effects / China - epidemiology / clevidipine injectable emulsion / Double-Blind Method / Drugs, Generic - administration & dosage / Drugs, Generic - adverse effects / Drugs, Generic - therapeutic use / efficacy / Female / Humans / Hypertension / Hypertension - drug therapy / Hypertensive Crisis / hypertensive emergencies and urgencies / Male / Middle Aged / Pyridines - administration & dosage / Pyridines - adverse effects / Pyridines - therapeutic use / safety / Treatment Outcome