Clinical trial NCT01361009: a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
Official title: Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 2017
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 3000

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:

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of AE/SAE
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
timeFrame: Baseline (Visit 1) and 12 weeks (Visit 3)
measure: The Dosage Related Information of Pramipexole at Baseline
timeFrame: baseline
measure: The Dosage Related Information of Pramipexole at the End of Study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 54
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 55
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 56
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 57
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 58
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 59
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 60
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 61
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 62
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 63
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 64
city: Beijing
country: China
facility: Boehringer Ingelheim Investigational Site 65
city: Changchun
country: China
facility: Boehringer Ingelheim Investigational Site 66
city: Changchun
country: China
facility: Boehringer Ingelheim Investigational Site 67
city: Changsh
country: China
facility: Boehringer Ingelheim Investigational Site 12
city: Changsh
country: China
facility: Boehringer Ingelheim Investigational Site 13
city: Changsh
country: China
facility: Boehringer Ingelheim Investigational Site 14
city: Changsh
country: China
facility: Boehringer Ingelheim Investigational Site 15
city: Changsh
country: China
facility: Boehringer Ingelheim Investigational Site 16
city: Chendu
country: China
facility: Boehringer Ingelheim Investigational Site 94
city: Chendu
country: China
facility: Boehringer Ingelheim Investigational Site 95
city: Chongqing
country: China
facility: Boehringer Ingelheim Investigational Site 100
city: Chongqing
country: China
facility: Boehringer Ingelheim Investigational Site 101
city: Chongqing
country: China
facility: Boehringer Ingelheim Investigational Site 97
city: Chongqing
country: China
facility: Boehringer Ingelheim Investigational Site 98
city: Chongqing
country: China
facility: Boehringer Ingelheim Investigational Site 99
city: Dalian
country: China
facility: Boehringer Ingelheim Investigational Site 71
city: Dalian
country: China
facility: Boehringer Ingelheim Investigational Site 72
city: Daqing
country: China
facility: Boehringer Ingelheim Investigational Site 79
city: Fuzhou
country: China
facility: Boehringer Ingelheim Investigational Site 35
city: Fuzhou
country: China
facility: Boehringer Ingelheim Investigational Site 36
city: Fuzhou
country: China
facility: Boehringer Ingelheim Investigational Site 37
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 80
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 81
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 82
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 83
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 84
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 85
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 86
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 87
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 88
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 89
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 90
city: Guangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 91
city: Haerbin
country: China
facility: Boehringer Ingelheim Investigational Site 77
city: Haerbin
country: China
facility: Boehringer Ingelheim Investigational Site 78
city: Hangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 28
city: Hangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 29
city: Hangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 30
city: Hangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 31
city: Hangzhou
country: China
facility: Boehringer Ingelheim Investigational Site 32
city: Hefei
country: China
facility: Boehringer Ingelheim Investigational Site 38
city: Jinan
country: China
facility: Boehringer Ingelheim Investigational Site 39
city: Jinan
country: China
facility: Boehringer Ingelheim Investigational Site 40
city: Luzhou
country: China
facility: Boehringer Ingelheim Investigational Site 96
city: Nanchang
country: China
facility: Boehringer Ingelheim Investigational Site 53
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site 44
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site 45
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site 46
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site 47
city: Nanjing
country: China
facility: Boehringer Ingelheim Investigational Site 48
city: Nantong
country: China
facility: Boehringer Ingelheim Investigational Site 49
city: Qingdao
country: China
facility: Boehringer Ingelheim Investigational Site 43
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 17
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 18
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 19
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 20
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 21
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 22
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 23
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 24
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 25
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 26
city: Shanghai
country: China
facility: Boehringer Ingelheim Investigational Site 27
city: Shantou
country: China
facility: Boehringer Ingelheim Investigational Site 92
city: Shenyang
country: China
facility: Boehringer Ingelheim Investigational Site 73
city: Shenyang
country: China
facility: Boehringer Ingelheim Investigational Site 74
city: Shenyang
country: China
facility: Boehringer Ingelheim Investigational Site 75
city: Shenyang
country: China
facility: Boehringer Ingelheim Investigational Site 76
city: Shenzhen
country: China
facility: Boehringer Ingelheim Investigational Site 93
city: Shijiazhuang
country: China
facility: Boehringer Ingelheim Investigational Site 2
city: Shijiazhuang
country: China
facility: Boehringer Ingelheim Investigational Site 3
city: Shiyan
country: China
facility: Boehringer Ingelheim Investigational Site 6
city: Suzhou
country: China
facility: Boehringer Ingelheim Investigational Site 51
city: Suzhou
country: China
facility: Boehringer Ingelheim Investigational Site 52
city: Taiyuan
country: China
facility: Boehringer Ingelheim Investigational Site 1
city: Tianjin
country: China
facility: Boehringer Ingelheim Investigational Site 68
city: Tianjin
country: China
facility: Boehringer Ingelheim Investigational Site 69
city: Tianjin
country: China
facility: Boehringer Ingelheim Investigational Site 70
city: Weifang
country: China
facility: Boehringer Ingelheim Investigational Site 41
city: Wenzhou
country: China
facility: Boehringer Ingelheim Investigational Site 33
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site 10
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site 11
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site 7
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site 8
city: Wuhan
country: China
facility: Boehringer Ingelheim Investigational Site 9
city: Wuxi
country: China
facility: Boehringer Ingelheim Investigational Site 50
city: Xiamen
country: China
facility: Boehringer Ingelheim Investigational Site 34
city: Xian
country: China
facility: Boehringer Ingelheim Investigational Site 102
city: Xian
country: China
facility: Boehringer Ingelheim Investigational Site 103
city: Yantai
country: China
facility: Boehringer Ingelheim Investigational Site 42
city: Zhengzhou
country: China
facility: Boehringer Ingelheim Investigational Site 4
city: Zhengzhou
country: China
facility: Boehringer Ingelheim Investigational Site 5
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: