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Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population. In order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in China, evaluate its safety and clinical benefit in a large Chinese population.
Cinepazide was firstly approved in France in 1974, and the formulations are injection and tablet. Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain, Italy. In some Aisa countries, it has not been re-registered in Japan in 2000s, and the injection is still used in China and Korea. In china, Cinepazide Maleate Injection was approved by China Food and Drug Administration(CFDA) in 2002, and widely used in cerebrovascular disease. The safety of the Cinepazide, especially the adverse drug reactions in the blood system, has not benn fully evaluated in Chinese population. In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection. This real world study for Cinepazide Maleate Injection with 18000 patients will be conducted from Sep. 2012 to June. 2014.
Age
All ages
Sex
ALL
Healthy Volunteers
No
China Rehabilitation Research Center
Beijing, Beijing Municipality, China
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
Beijing, Beijing Municipality, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Fu Xing Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
Beijing, Beijing Municipality, China
Hua Xin Hospital; First Hospital of Tsing Hua University
Beijing, Beijing Municipality, China
Xuanwu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
Start Date
October 1, 2012
Primary Completion Date
December 1, 2021
Completion Date
June 1, 2022
Last Updated
July 27, 2022
18,260
ACTUAL participants
Lead Sponsor
Peking University Third Hospital
Collaborators
NCT07371455
NCT05093673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06258538