a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
1 other identifier
observational
2,017
1 country
103
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Shorter than P25 for all trials
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
August 30, 2013
CompletedMay 16, 2014
June 1, 2013
9 months
May 23, 2011
January 31, 2013
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of AE/SAE
The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.
12 weeks
Secondary Outcomes (3)
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
Baseline (Visit 1) and 12 weeks (Visit 3)
The Dosage Related Information of Pramipexole at Baseline
baseline
The Dosage Related Information of Pramipexole at the End of Study
12 weeks
Study Arms (1)
pramipexole group
It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
Interventions
Eligibility Criteria
3000
You may qualify if:
- Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria
- Age: from 30 to 75 years old
- Stage I-IV of revised Hoehn-Yahr standards
- With current use of pramipexole
- Informed consent signed by every subject
You may not qualify if:
- Diagnosis of Parkinson¿s syndrome
- Current use of psychotolytic medications
- Allergic to pramipexole or any other ingredient of pramipexole
- Female patients in pregnancy and lactation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Boehringer Ingelheim Investigational Site 54
Beijing, China
Boehringer Ingelheim Investigational Site 55
Beijing, China
Boehringer Ingelheim Investigational Site 56
Beijing, China
Boehringer Ingelheim Investigational Site 57
Beijing, China
Boehringer Ingelheim Investigational Site 58
Beijing, China
Boehringer Ingelheim Investigational Site 59
Beijing, China
Boehringer Ingelheim Investigational Site 60
Beijing, China
Boehringer Ingelheim Investigational Site 61
Beijing, China
Boehringer Ingelheim Investigational Site 62
Beijing, China
Boehringer Ingelheim Investigational Site 63
Beijing, China
Boehringer Ingelheim Investigational Site 64
Beijing, China
Boehringer Ingelheim Investigational Site 65
Beijing, China
Boehringer Ingelheim Investigational Site 66
Changchun, China
Boehringer Ingelheim Investigational Site 67
Changchun, China
Boehringer Ingelheim Investigational Site 12
Changsh, China
Boehringer Ingelheim Investigational Site 13
Changsh, China
Boehringer Ingelheim Investigational Site 14
Changsh, China
Boehringer Ingelheim Investigational Site 15
Changsh, China
Boehringer Ingelheim Investigational Site 16
Changsh, China
Boehringer Ingelheim Investigational Site 94
Chendu, China
Boehringer Ingelheim Investigational Site 95
Chendu, China
Boehringer Ingelheim Investigational Site 100
Chongqing, China
Boehringer Ingelheim Investigational Site 101
Chongqing, China
Boehringer Ingelheim Investigational Site 97
Chongqing, China
Boehringer Ingelheim Investigational Site 98
Chongqing, China
Boehringer Ingelheim Investigational Site 99
Chongqing, China
Boehringer Ingelheim Investigational Site 71
Dalian, China
Boehringer Ingelheim Investigational Site 72
Dalian, China
Boehringer Ingelheim Investigational Site 79
Daqing, China
Boehringer Ingelheim Investigational Site 35
Fuzhou, China
Boehringer Ingelheim Investigational Site 36
Fuzhou, China
Boehringer Ingelheim Investigational Site 37
Fuzhou, China
Boehringer Ingelheim Investigational Site 80
Guangzhou, China
Boehringer Ingelheim Investigational Site 81
Guangzhou, China
Boehringer Ingelheim Investigational Site 82
Guangzhou, China
Boehringer Ingelheim Investigational Site 83
Guangzhou, China
Boehringer Ingelheim Investigational Site 84
Guangzhou, China
Boehringer Ingelheim Investigational Site 85
Guangzhou, China
Boehringer Ingelheim Investigational Site 86
Guangzhou, China
Boehringer Ingelheim Investigational Site 87
Guangzhou, China
Boehringer Ingelheim Investigational Site 88
Guangzhou, China
Boehringer Ingelheim Investigational Site 89
Guangzhou, China
Boehringer Ingelheim Investigational Site 90
Guangzhou, China
Boehringer Ingelheim Investigational Site 91
Guangzhou, China
Boehringer Ingelheim Investigational Site 77
Haerbin, China
Boehringer Ingelheim Investigational Site 78
Haerbin, China
Boehringer Ingelheim Investigational Site 28
Hangzhou, China
Boehringer Ingelheim Investigational Site 29
Hangzhou, China
Boehringer Ingelheim Investigational Site 30
Hangzhou, China
Boehringer Ingelheim Investigational Site 31
Hangzhou, China
Boehringer Ingelheim Investigational Site 32
Hangzhou, China
Boehringer Ingelheim Investigational Site 38
Hefei, China
Boehringer Ingelheim Investigational Site 39
Jinan, China
Boehringer Ingelheim Investigational Site 40
Jinan, China
Boehringer Ingelheim Investigational Site 96
Luzhou, China
Boehringer Ingelheim Investigational Site 53
Nanchang, China
Boehringer Ingelheim Investigational Site 44
Nanjing, China
Boehringer Ingelheim Investigational Site 45
Nanjing, China
Boehringer Ingelheim Investigational Site 46
Nanjing, China
Boehringer Ingelheim Investigational Site 47
Nanjing, China
Boehringer Ingelheim Investigational Site 48
Nanjing, China
Boehringer Ingelheim Investigational Site 49
Nantong, China
Boehringer Ingelheim Investigational Site 43
Qingdao, China
Boehringer Ingelheim Investigational Site 17
Shanghai, China
Boehringer Ingelheim Investigational Site 18
Shanghai, China
Boehringer Ingelheim Investigational Site 19
Shanghai, China
Boehringer Ingelheim Investigational Site 20
Shanghai, China
Boehringer Ingelheim Investigational Site 21
Shanghai, China
Boehringer Ingelheim Investigational Site 22
Shanghai, China
Boehringer Ingelheim Investigational Site 23
Shanghai, China
Boehringer Ingelheim Investigational Site 24
Shanghai, China
Boehringer Ingelheim Investigational Site 25
Shanghai, China
Boehringer Ingelheim Investigational Site 26
Shanghai, China
Boehringer Ingelheim Investigational Site 27
Shanghai, China
Boehringer Ingelheim Investigational Site 92
Shantou, China
Boehringer Ingelheim Investigational Site 73
Shenyang, China
Boehringer Ingelheim Investigational Site 74
Shenyang, China
Boehringer Ingelheim Investigational Site 75
Shenyang, China
Boehringer Ingelheim Investigational Site 76
Shenyang, China
Boehringer Ingelheim Investigational Site 93
Shenzhen, China
Boehringer Ingelheim Investigational Site 2
Shijiazhuang, China
Boehringer Ingelheim Investigational Site 3
Shijiazhuang, China
Boehringer Ingelheim Investigational Site 6
Shiyan, China
Boehringer Ingelheim Investigational Site 51
Suzhou, China
Boehringer Ingelheim Investigational Site 52
Suzhou, China
Boehringer Ingelheim Investigational Site 1
Taiyuan, China
Boehringer Ingelheim Investigational Site 68
Tianjin, China
Boehringer Ingelheim Investigational Site 69
Tianjin, China
Boehringer Ingelheim Investigational Site 70
Tianjin, China
Boehringer Ingelheim Investigational Site 41
Weifang, China
Boehringer Ingelheim Investigational Site 33
Wenzhou, China
Boehringer Ingelheim Investigational Site 10
Wuhan, China
Boehringer Ingelheim Investigational Site 11
Wuhan, China
Boehringer Ingelheim Investigational Site 7
Wuhan, China
Boehringer Ingelheim Investigational Site 8
Wuhan, China
Boehringer Ingelheim Investigational Site 9
Wuhan, China
Boehringer Ingelheim Investigational Site 50
Wuxi, China
Boehringer Ingelheim Investigational Site 102
Xi'an, China
Boehringer Ingelheim Investigational Site 103
Xi'an, China
Boehringer Ingelheim Investigational Site 34
Xiamen, China
Boehringer Ingelheim Investigational Site 42
Yantai, China
Boehringer Ingelheim Investigational Site 4
Zhengzhou, China
Boehringer Ingelheim Investigational Site 5
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 26, 2011
Study Start
May 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 16, 2014
Results First Posted
August 30, 2013
Record last verified: 2013-06