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Adverse Drug ReactionPACERNCT01946919

Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

An observational study of Adverse Drug Reaction and Cinepazide, run by Peking University Third Hospital at 61 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Adverse Drug Reaction, Cinepazide, Stroke
How many people
18,260 participants
Where
61 sitesChina
Study dates
Oct 2012to Jun 2022
How long will I take part?
14 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.

Who may be able to join

  • Inpatient using the cinepazide in the department of neurology

Who cannot join

  • none

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

China61 sites
  • Ankang City Central Hospital

    Ankang, Shaanxi, 725000

  • China Rehabilitation Research Center

    Beijing, Beijing Municipality, 100000

  • Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)

    Beijing, Beijing Municipality, 100000

  • Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100005

  • Fu Xing Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100009

  • Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)

    Beijing, Beijing Municipality, 100011

  • Hua Xin Hospital; First Hospital of Tsing Hua University

    Beijing, Beijing Municipality, 100011

  • Xuanwu Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university

    Beijing, Beijing Municipality, 100191

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Binzhou People's Hospital

    Binzhou, Shandong, 256600

  • Jilin Province People's Hospital

    Changchun, Jilin, 130000

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410000

  • The First Hospital of Changsha

    Changsha, Hunan, 410000

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • The Third Hospital of Changsha

    Changsha, Hunan, 410000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410000

  • Central People's Hospital of Zhanjiang

    Ganjiang, Guangdong, 524000

  • The People's Hospital of Gaozhou

    Gaozhou, Guangdong, 525200

  • GuangZhou First People's Hospital

    Guangzhou, Guangdong, 510000

  • Panyu Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • San Er Ling Yi Hospital

    Hanzhong, Shaanxi, 723000

  • People's Hospital of Heilongjiang Province

    Harbin, Heilongjiang, 150000

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine

    Harbin, Heilongjiang, 150000

  • The first hospital of Harbin City

    Harbin, Heilongjiang, 150000

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

  • The Second Affiliated of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150000

  • Affiliated Hospital of Beihua University

    Jilin City, Jilin, 132000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The Third Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330000

  • Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University

    Shantou, Guangdong, 510000

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515000

  • General Hospital of Shenyang military area command of Chinese PLA

    Shenyang, Liaoning, 110000

  • Shenyang First People's Hospital

    Shenyang, Liaoning, 110000

  • Shenzhou Hospital to Shenyang Medical College

    Shenyang, Liaoning, 110000

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The four six three hospital of people's Liberation Army

    Shenyang, Liaoning, 110000

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • The people's Liberation Army 202nd hospital

    Shenyang, Liaoning, 110000

  • People's Hospital of Dongxihu District

    Wuhan, Hebei, 430040

  • Shenlong Hospital

    Wuhan, Hebei, 430050

  • Renmin Hospital of Wuhan

    Wuhan, Hubei, 430000

  • Tongji Hospital

    Wuhan, Hubei, 430000

  • Wuhan Union Hospital

    Wuhan, Hubei, 430000

  • First Affiliated Hospital of Medical College of Xian Jiaotong University

    Xi'an, Shaanxi, 710000

  • Tangdu Hospital

    Xi'an, Shaanxi, 710000

  • The Central Hospital of Xi'an

    Xi'an, Shaanxi, 710000

  • Xijing Hospital

    Xi'an, Shaanxi, 710000

  • Hospital of Traditional Chinese Medicine of Zhongshan

    Zhongshan, Guangdong, 528400

Other trials in China

About this study

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.

Read the detailed description

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.

Keywords
Cinepazide, Adverse Drug Reaction, Safety, Real World Study
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01946919
Study groupRoleWhat they receive
cinepazideInpatient using the cinepazide in department of neurology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse drug reaction of cinepazide in department of neurology

    Measured: 1.5 years

Secondary outcomes (4)
  1. Outcomes of the patients who experienced an adverse drug reaction of cinepazide.

    Outcomes including cure, improved, null, or death.

    Measured: 1.5 years

  2. The predictors of the adverse drug reaction of cinepazide

    We will analyse whether some factors, such as age, gender, medical history and etc, would be the predictors of the adverse drug reaction of cinepazide.

    Measured: 1.5 years

  3. Types of the adverse drug reaction of cinepazide.

    The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.

    Measured: 1.5 years

  4. The treatment when patients experienced an adverse drug reaction of cinepazide.

    Treatments including oxygen, steroids, and etc. According to severity of the adverse drug reactions, we will analyse the features the treatments, such as types and numbers.

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2021
  4. Study completionJun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18,260 participants (actual)
Target duration
14 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946919
Sponsor's protocol ID
PekingUTH-Pharmacy-002
Acronym
PACER
Status last verified
Oct 2026
First submitted
12 Sep 2013
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Adverse Drug Reaction and Cinepazide, run by Peking University Third Hospital at 61 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse drug reaction of cinepazide in department of neurology (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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