a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01361009
Collaborator
(none)
2,017
103
9.1
19.6
2.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Purpose:
Study Design
Study Type:
Observational
Actual Enrollment
:
2017 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance
Study Start Date
:
May 1, 2011
Actual Primary Completion Date
:
Feb 1, 2012
Actual Study Completion Date
:
Feb 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| pramipexole group It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
Drug: pramipexole
as prescibed by the investigator
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Baseline [baseline]
At enrollment, the distribution of patients in 3 pramipexole dosage categories.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
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
Exclusion criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Investigational Site 54 | Beijing | China | ||
| 2 | Boehringer Ingelheim Investigational Site 55 | Beijing | China | ||
| 3 | Boehringer Ingelheim Investigational Site 56 | Beijing | China | ||
| 4 | Boehringer Ingelheim Investigational Site 57 | Beijing | China | ||
| 5 | Boehringer Ingelheim Investigational Site 58 | Beijing | China | ||
| 6 | Boehringer Ingelheim Investigational Site 59 | Beijing | China | ||
| 7 | Boehringer Ingelheim Investigational Site 60 | Beijing | China | ||
| 8 | Boehringer Ingelheim Investigational Site 61 | Beijing | China | ||
| 9 | Boehringer Ingelheim Investigational Site 62 | Beijing | China | ||
| 10 | Boehringer Ingelheim Investigational Site 63 | Beijing | China | ||
| 11 | Boehringer Ingelheim Investigational Site 64 | Beijing | China | ||
| 12 | Boehringer Ingelheim Investigational Site 65 | Beijing | China | ||
| 13 | Boehringer Ingelheim Investigational Site 66 | Changchun | China | ||
| 14 | Boehringer Ingelheim Investigational Site 67 | Changchun | China | ||
| 15 | Boehringer Ingelheim Investigational Site 12 | Changsh | China | ||
| 16 | Boehringer Ingelheim Investigational Site 13 | Changsh | China | ||
| 17 | Boehringer Ingelheim Investigational Site 14 | Changsh | China | ||
| 18 | Boehringer Ingelheim Investigational Site 15 | Changsh | China | ||
| 19 | Boehringer Ingelheim Investigational Site 16 | Changsh | China | ||
| 20 | Boehringer Ingelheim Investigational Site 94 | Chendu | China | ||
| 21 | Boehringer Ingelheim Investigational Site 95 | Chendu | China | ||
| 22 | Boehringer Ingelheim Investigational Site 100 | Chongqing | China | ||
| 23 | Boehringer Ingelheim Investigational Site 101 | Chongqing | China | ||
| 24 | Boehringer Ingelheim Investigational Site 97 | Chongqing | China | ||
| 25 | Boehringer Ingelheim Investigational Site 98 | Chongqing | China | ||
| 26 | Boehringer Ingelheim Investigational Site 99 | Chongqing | China | ||
| 27 | Boehringer Ingelheim Investigational Site 71 | Dalian | China | ||
| 28 | Boehringer Ingelheim Investigational Site 72 | Dalian | China | ||
| 29 | Boehringer Ingelheim Investigational Site 79 | Daqing | China | ||
| 30 | Boehringer Ingelheim Investigational Site 35 | Fuzhou | China | ||
| 31 | Boehringer Ingelheim Investigational Site 36 | Fuzhou | China | ||
| 32 | Boehringer Ingelheim Investigational Site 37 | Fuzhou | China | ||
| 33 | Boehringer Ingelheim Investigational Site 80 | Guangzhou | China | ||
| 34 | Boehringer Ingelheim Investigational Site 81 | Guangzhou | China | ||
| 35 | Boehringer Ingelheim Investigational Site 82 | Guangzhou | China | ||
| 36 | Boehringer Ingelheim Investigational Site 83 | Guangzhou | China | ||
| 37 | Boehringer Ingelheim Investigational Site 84 | Guangzhou | China | ||
| 38 | Boehringer Ingelheim Investigational Site 85 | Guangzhou | China | ||
| 39 | Boehringer Ingelheim Investigational Site 86 | Guangzhou | China | ||
| 40 | Boehringer Ingelheim Investigational Site 87 | Guangzhou | China | ||
| 41 | Boehringer Ingelheim Investigational Site 88 | Guangzhou | China | ||
| 42 | Boehringer Ingelheim Investigational Site 89 | Guangzhou | China | ||
| 43 | Boehringer Ingelheim Investigational Site 90 | Guangzhou | China | ||
| 44 | Boehringer Ingelheim Investigational Site 91 | Guangzhou | China | ||
| 45 | Boehringer Ingelheim Investigational Site 77 | Haerbin | China | ||
| 46 | Boehringer Ingelheim Investigational Site 78 | Haerbin | China | ||
| 47 | Boehringer Ingelheim Investigational Site 28 | Hangzhou | China | ||
| 48 | Boehringer Ingelheim Investigational Site 29 | Hangzhou | China | ||
| 49 | Boehringer Ingelheim Investigational Site 30 | Hangzhou | China | ||
| 50 | Boehringer Ingelheim Investigational Site 31 | Hangzhou | China | ||
| 51 | Boehringer Ingelheim Investigational Site 32 | Hangzhou | China | ||
| 52 | Boehringer Ingelheim Investigational Site 38 | Hefei | China | ||
| 53 | Boehringer Ingelheim Investigational Site 39 | Jinan | China | ||
| 54 | Boehringer Ingelheim Investigational Site 40 | Jinan | China | ||
| 55 | Boehringer Ingelheim Investigational Site 96 | Luzhou | China | ||
| 56 | Boehringer Ingelheim Investigational Site 53 | Nanchang | China | ||
| 57 | Boehringer Ingelheim Investigational Site 44 | Nanjing | China | ||
| 58 | Boehringer Ingelheim Investigational Site 45 | Nanjing | China | ||
| 59 | Boehringer Ingelheim Investigational Site 46 | Nanjing | China | ||
| 60 | Boehringer Ingelheim Investigational Site 47 | Nanjing | China | ||
| 61 | Boehringer Ingelheim Investigational Site 48 | Nanjing | China | ||
| 62 | Boehringer Ingelheim Investigational Site 49 | Nantong | China | ||
| 63 | Boehringer Ingelheim Investigational Site 43 | Qingdao | China | ||
| 64 | Boehringer Ingelheim Investigational Site 17 | Shanghai | China | ||
| 65 | Boehringer Ingelheim Investigational Site 18 | Shanghai | China | ||
| 66 | Boehringer Ingelheim Investigational Site 19 | Shanghai | China | ||
| 67 | Boehringer Ingelheim Investigational Site 20 | Shanghai | China | ||
| 68 | Boehringer Ingelheim Investigational Site 21 | Shanghai | China | ||
| 69 | Boehringer Ingelheim Investigational Site 22 | Shanghai | China | ||
| 70 | Boehringer Ingelheim Investigational Site 23 | Shanghai | China | ||
| 71 | Boehringer Ingelheim Investigational Site 24 | Shanghai | China | ||
| 72 | Boehringer Ingelheim Investigational Site 25 | Shanghai | China | ||
| 73 | Boehringer Ingelheim Investigational Site 26 | Shanghai | China | ||
| 74 | Boehringer Ingelheim Investigational Site 27 | Shanghai | China | ||
| 75 | Boehringer Ingelheim Investigational Site 92 | Shantou | China | ||
| 76 | Boehringer Ingelheim Investigational Site 73 | Shenyang | China | ||
| 77 | Boehringer Ingelheim Investigational Site 74 | Shenyang | China | ||
| 78 | Boehringer Ingelheim Investigational Site 75 | Shenyang | China | ||
| 79 | Boehringer Ingelheim Investigational Site 76 | Shenyang | China | ||
| 80 | Boehringer Ingelheim Investigational Site 93 | Shenzhen | China | ||
| 81 | Boehringer Ingelheim Investigational Site 2 | Shijiazhuang | China | ||
| 82 | Boehringer Ingelheim Investigational Site 3 | Shijiazhuang | China | ||
| 83 | Boehringer Ingelheim Investigational Site 6 | Shiyan | China | ||
| 84 | Boehringer Ingelheim Investigational Site 51 | Suzhou | China | ||
| 85 | Boehringer Ingelheim Investigational Site 52 | Suzhou | China | ||
| 86 | Boehringer Ingelheim Investigational Site 1 | Taiyuan | China | ||
| 87 | Boehringer Ingelheim Investigational Site 68 | Tianjin | China | ||
| 88 | Boehringer Ingelheim Investigational Site 69 | Tianjin | China | ||
| 89 | Boehringer Ingelheim Investigational Site 70 | Tianjin | China | ||
| 90 | Boehringer Ingelheim Investigational Site 41 | Weifang | China | ||
| 91 | Boehringer Ingelheim Investigational Site 33 | Wenzhou | China | ||
| 92 | Boehringer Ingelheim Investigational Site 10 | Wuhan | China | ||
| 93 | Boehringer Ingelheim Investigational Site 11 | Wuhan | China | ||
| 94 | Boehringer Ingelheim Investigational Site 7 | Wuhan | China | ||
| 95 | Boehringer Ingelheim Investigational Site 8 | Wuhan | China | ||
| 96 | Boehringer Ingelheim Investigational Site 9 | Wuhan | China | ||
| 97 | Boehringer Ingelheim Investigational Site 50 | Wuxi | China | ||
| 98 | Boehringer Ingelheim Investigational Site 34 | Xiamen | China | ||
| 99 | Boehringer Ingelheim Investigational Site 102 | Xian | China | ||
| 100 | Boehringer Ingelheim Investigational Site 103 | Xian | China | ||
| 101 | Boehringer Ingelheim Investigational Site 42 | Yantai | China | ||
| 102 | Boehringer Ingelheim Investigational Site 4 | Zhengzhou | China | ||
| 103 | Boehringer Ingelheim Investigational Site 5 | Zhengzhou | China |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01361009
Other Study ID Numbers:
- 248.682
First Posted:
May 26, 2011
Last Update Posted:
May 16, 2014
Last Verified:
Jun 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
| Period Title: Overall Study | |
| STARTED | 2017 |
| COMPLETED | 1901 |
| NOT COMPLETED | 116 |
Baseline Characteristics
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | |
| Overall Participants | 2017 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.09
(9.67)
|
| Gender (Number of participants) [Number] | |
| Female |
840
41.6%
|
| Male |
1174
58.2%
|
| Course of Parkinson's disease (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
3
(2.5)
|
Outcome Measures
| Title | Incidence of AE/SAE |
|---|---|
| Description | The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment. |
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
| Measure Participants | 2017 |
| Number [Percentage of participants] |
5.16
0.3%
|
| Title | Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) |
|---|---|
| Description | 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). |
| Time Frame | Baseline (Visit 1) and 12 weeks (Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3. |
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
| Measure Participants | 1891 |
| Visit 1 |
3.53
(1.23)
|
| Visit 3 |
2.48
(0.69)
|
| Title | The Dosage Related Information of Pramipexole at Baseline |
|---|---|
| Description | At enrollment, the distribution of patients in 3 pramipexole dosage categories. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 2017 patients in SAS set. |
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
| Measure Participants | 2017 |
| dosage < 0.75mg/d |
84.93
|
| 1.5mg/d > dosage ≥ 0.75mg/d |
12.99
|
| dosage ≥ 1.5mg/d |
2.08
|
| Title | The Dosage Related Information of Pramipexole at the End of Study |
|---|---|
| Description | At the end of study, the distribution of patients in 3 pramipexole dosage categories. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 2017 patients in SAS set |
| Arm/Group Title | Pramipexole Goup |
|---|---|
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. |
| Measure Participants | 2017 |
| dosage < 0.75mg/d |
33.56
|
| 1.5mg/d > dosage ≥ 0.75mg/d |
46.16
|
| dosage ≥ 1.5mg/d |
20.28
|
Adverse Events
| Time Frame | 12 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pramipexole Goup | |
| Arm/Group Description | An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world. | |
All Cause Mortality |
||
| Pramipexole Goup | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Pramipexole Goup | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2017 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Pramipexole Goup | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2017 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01361009
Other Study ID Numbers:
- 248.682
First Posted:
May 26, 2011
Last Update Posted:
May 16, 2014
Last Verified:
Jun 1, 2013