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a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

NCT ID: NCT01361009

Last Updated: 2014-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2017 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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This is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. Parkinson disease patients with different severity who have already used pramipexole could be observed in this study. In the whole observation period, treatment decision was determined by physician and patient completely. The safety endpoint is AE(Adverse Event), SAE(Serious Adverse Event), patient withdraw, laboratory test.

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Detailed Description

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Purpose:

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pramipexole group

It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.

pramipexole

Intervention Type DRUG

as prescibed by the investigator

Interventions

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pramipexole

as prescibed by the investigator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria
2. Age: from 30 to 75 years old
3. Stage I-IV of revised Hoehn-Yahr standards
4. With current use of pramipexole
5. Informed consent signed by every subject

Exclusion Criteria

1. Diagnosis of Parkinson¿s syndrome
2. Current use of psychotolytic medications
3. Allergic to pramipexole or any other ingredient of pramipexole
4. Female patients in pregnancy and lactation
5. Patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 54

Beijing, , China

Site Status

Boehringer Ingelheim Investigational Site 55

Beijing, , China

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Boehringer Ingelheim Investigational Site 56

Beijing, , China

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Boehringer Ingelheim Investigational Site 57

Beijing, , China

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Boehringer Ingelheim Investigational Site 58

Beijing, , China

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Boehringer Ingelheim Investigational Site 59

Beijing, , China

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Boehringer Ingelheim Investigational Site 60

Beijing, , China

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Boehringer Ingelheim Investigational Site 61

Beijing, , China

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Boehringer Ingelheim Investigational Site 62

Beijing, , China

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Boehringer Ingelheim Investigational Site 63

Beijing, , China

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Boehringer Ingelheim Investigational Site 64

Beijing, , China

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Boehringer Ingelheim Investigational Site 65

Beijing, , China

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Boehringer Ingelheim Investigational Site 66

Changchun, , China

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Boehringer Ingelheim Investigational Site 67

Changchun, , China

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Boehringer Ingelheim Investigational Site 12

Changsh, , China

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Boehringer Ingelheim Investigational Site 13

Changsh, , China

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Boehringer Ingelheim Investigational Site 14

Changsh, , China

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Boehringer Ingelheim Investigational Site 15

Changsh, , China

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Boehringer Ingelheim Investigational Site 16

Changsh, , China

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Boehringer Ingelheim Investigational Site 94

Chendu, , China

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Boehringer Ingelheim Investigational Site 95

Chendu, , China

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Boehringer Ingelheim Investigational Site 100

Chongqing, , China

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Boehringer Ingelheim Investigational Site 101

Chongqing, , China

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Boehringer Ingelheim Investigational Site 97

Chongqing, , China

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Boehringer Ingelheim Investigational Site 98

Chongqing, , China

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Boehringer Ingelheim Investigational Site 99

Chongqing, , China

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Boehringer Ingelheim Investigational Site 71

Dalian, , China

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Boehringer Ingelheim Investigational Site 72

Dalian, , China

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Boehringer Ingelheim Investigational Site 79

Daqing, , China

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Boehringer Ingelheim Investigational Site 35

Fuzhou, , China

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Boehringer Ingelheim Investigational Site 36

Fuzhou, , China

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Boehringer Ingelheim Investigational Site 37

Fuzhou, , China

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Boehringer Ingelheim Investigational Site 80

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 81

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 82

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 83

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 84

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 85

Guangzhou, , China

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Boehringer Ingelheim Investigational Site 86

Guangzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Boehringer Ingelheim Investigational Site 90

Guangzhou, , China

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Guangzhou, , China

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Boehringer Ingelheim Investigational Site 77

Haerbin, , China

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Boehringer Ingelheim Investigational Site 78

Haerbin, , China

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Boehringer Ingelheim Investigational Site 28

Hangzhou, , China

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Boehringer Ingelheim Investigational Site 29

Hangzhou, , China

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Boehringer Ingelheim Investigational Site 30

Hangzhou, , China

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Boehringer Ingelheim Investigational Site 31

Hangzhou, , China

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Hangzhou, , China

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Boehringer Ingelheim Investigational Site 38

Hefei, , China

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Boehringer Ingelheim Investigational Site 39

Jinan, , China

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Boehringer Ingelheim Investigational Site 40

Jinan, , China

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Boehringer Ingelheim Investigational Site 96

Luzhou, , China

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Boehringer Ingelheim Investigational Site 53

Nanchang, , China

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Boehringer Ingelheim Investigational Site 44

Nanjing, , China

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Boehringer Ingelheim Investigational Site 45

Nanjing, , China

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Boehringer Ingelheim Investigational Site 46

Nanjing, , China

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Nanjing, , China

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Nanjing, , China

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Nantong, , China

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Qingdao, , China

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Boehringer Ingelheim Investigational Site 17

Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Boehringer Ingelheim Investigational Site 23

Shanghai, , China

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Boehringer Ingelheim Investigational Site 24

Shanghai, , China

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Boehringer Ingelheim Investigational Site 25

Shanghai, , China

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Boehringer Ingelheim Investigational Site 26

Shanghai, , China

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Boehringer Ingelheim Investigational Site 27

Shanghai, , China

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Boehringer Ingelheim Investigational Site 92

Shantou, , China

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Boehringer Ingelheim Investigational Site 73

Shenyang, , China

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Boehringer Ingelheim Investigational Site 74

Shenyang, , China

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Boehringer Ingelheim Investigational Site 75

Shenyang, , China

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Boehringer Ingelheim Investigational Site 76

Shenyang, , China

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Boehringer Ingelheim Investigational Site 93

Shenzhen, , China

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Boehringer Ingelheim Investigational Site 2

Shijiazhuang, , China

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Boehringer Ingelheim Investigational Site 3

Shijiazhuang, , China

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Boehringer Ingelheim Investigational Site 6

Shiyan, , China

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Boehringer Ingelheim Investigational Site 51

Suzhou, , China

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Boehringer Ingelheim Investigational Site 52

Suzhou, , China

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Boehringer Ingelheim Investigational Site 1

Taiyuan, , China

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Boehringer Ingelheim Investigational Site 68

Tianjin, , China

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Boehringer Ingelheim Investigational Site 69

Tianjin, , China

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Boehringer Ingelheim Investigational Site 70

Tianjin, , China

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Boehringer Ingelheim Investigational Site 41

Weifang, , China

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Boehringer Ingelheim Investigational Site 33

Wenzhou, , China

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Boehringer Ingelheim Investigational Site 10

Wuhan, , China

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Boehringer Ingelheim Investigational Site 11

Wuhan, , China

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Boehringer Ingelheim Investigational Site 7

Wuhan, , China

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Boehringer Ingelheim Investigational Site 8

Wuhan, , China

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Boehringer Ingelheim Investigational Site 9

Wuhan, , China

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Boehringer Ingelheim Investigational Site 50

Wuxi, , China

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Boehringer Ingelheim Investigational Site 102

Xi'an, , China

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Boehringer Ingelheim Investigational Site 103

Xi'an, , China

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Boehringer Ingelheim Investigational Site 34

Xiamen, , China

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Boehringer Ingelheim Investigational Site 42

Yantai, , China

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Boehringer Ingelheim Investigational Site 4

Zhengzhou, , China

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Boehringer Ingelheim Investigational Site 5

Zhengzhou, , China

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Countries

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China

Other Identifiers

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248.682

Identifier Type: -

Identifier Source: org_study_id

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