a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
- Registration Number
- NCT01361009
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Purpose:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2017
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pramipexole group pramipexole It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
- Primary Outcome Measures
Name Time Method Incidence of AE/SAE 12 weeks The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.
- Secondary Outcome Measures
Name Time Method The Dosage Related Information of Pramipexole at Baseline baseline At enrollment, the distribution of patients in 3 pramipexole dosage categories.
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) Baseline (Visit 1) and 12 weeks (Visit 3) Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).
The Dosage Related Information of Pramipexole at the End of Study 12 weeks At the end of study, the distribution of patients in 3 pramipexole dosage categories.
Trial Locations
- Locations (103)
Boehringer Ingelheim Investigational Site 52
🇨🇳Suzhou, China
Boehringer Ingelheim Investigational Site 57
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 60
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 67
🇨🇳Changchun, China
Boehringer Ingelheim Investigational Site 99
🇨🇳Chongqing, China
Boehringer Ingelheim Investigational Site 78
🇨🇳Haerbin, China
Boehringer Ingelheim Investigational Site 28
🇨🇳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 92
🇨🇳Shantou, China
Boehringer Ingelheim Investigational Site 74
🇨🇳Shenyang, China
Boehringer Ingelheim Investigational Site 51
🇨🇳Suzhou, China
Boehringer Ingelheim Investigational Site 70
🇨🇳Tianjin, China
Boehringer Ingelheim Investigational Site 7
🇨🇳Wuhan, China
Boehringer Ingelheim Investigational Site 102
🇨🇳Xian, China
Boehringer Ingelheim Investigational Site 103
🇨🇳Xian, China
Boehringer Ingelheim Investigational Site 58
🇨🇳Beijing, China
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 61
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 12
🇨🇳Changsh, China
Boehringer Ingelheim Investigational Site 62
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 65
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 63
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 66
🇨🇳Changchun, China
Boehringer Ingelheim Investigational Site 64
🇨🇳Beijing, 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 72
🇨🇳Dalian, 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 71
🇨🇳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 29
🇨🇳Hangzhou, China
Boehringer Ingelheim Investigational Site 30
🇨🇳Hangzhou, China
Boehringer Ingelheim Investigational Site 40
🇨🇳Jinan, China
Boehringer Ingelheim Investigational Site 53
🇨🇳Nanchang, China
Boehringer Ingelheim Investigational Site 96
🇨🇳Luzhou, China
Boehringer Ingelheim Investigational Site 49
🇨🇳Nantong, China
Boehringer Ingelheim Investigational Site 43
🇨🇳Qingdao, China
Boehringer Ingelheim Investigational Site 46
🇨🇳Nanjing, 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 73
🇨🇳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 1
🇨🇳Taiyuan, China
Boehringer Ingelheim Investigational Site 68
🇨🇳Tianjin, China
Boehringer Ingelheim Investigational Site 69
🇨🇳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 8
🇨🇳Wuhan, China
Boehringer Ingelheim Investigational Site 9
🇨🇳Wuhan, China
Boehringer Ingelheim Investigational Site 50
🇨🇳Wuxi, China
Boehringer Ingelheim Investigational Site 34
🇨🇳Xiamen, China
Boehringer Ingelheim Investigational Site 42
🇨🇳Yantai, China
Boehringer Ingelheim Investigational Site 5
🇨🇳Zhengzhou, China
Boehringer Ingelheim Investigational Site 4
🇨🇳Zhengzhou, China
Boehringer Ingelheim Investigational Site 59
🇨🇳Beijing, China
Boehringer Ingelheim Investigational Site 44
🇨🇳Nanjing, China
Boehringer Ingelheim Investigational Site 45
🇨🇳Nanjing, China
Boehringer Ingelheim Investigational Site 47
🇨🇳Nanjing, China
Boehringer Ingelheim Investigational Site 48
🇨🇳Nanjing, China