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

May 7, 2014 updated by: Boehringer Ingelheim

Safety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing Surveillance

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2017

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • 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 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
      • Changchun, China
        • Boehringer Ingelheim Investigational Site 66
      • Changchun, China
        • Boehringer Ingelheim Investigational Site 67
      • Changsh, 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
      • Chendu, China
        • Boehringer Ingelheim Investigational Site 94
      • Chendu, China
        • Boehringer Ingelheim Investigational Site 95
      • Chongqing, 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
      • Dalian, China
        • Boehringer Ingelheim Investigational Site 71
      • Dalian, China
        • Boehringer Ingelheim Investigational Site 72
      • Daqing, China
        • Boehringer Ingelheim Investigational Site 79
      • Fuzhou, China
        • Boehringer Ingelheim Investigational Site 35
      • Fuzhou, China
        • Boehringer Ingelheim Investigational Site 36
      • Fuzhou, China
        • Boehringer Ingelheim Investigational Site 37
      • Guangzhou, 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
      • Haerbin, China
        • Boehringer Ingelheim Investigational Site 77
      • Haerbin, China
        • Boehringer Ingelheim Investigational Site 78
      • Hangzhou, 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
      • Hefei, China
        • Boehringer Ingelheim Investigational Site 38
      • Jinan, China
        • Boehringer Ingelheim Investigational Site 39
      • Jinan, China
        • Boehringer Ingelheim Investigational Site 40
      • Luzhou, China
        • Boehringer Ingelheim Investigational Site 96
      • Nanchang, China
        • Boehringer Ingelheim Investigational Site 53
      • Nanjing, 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
      • Nantong, China
        • Boehringer Ingelheim Investigational Site 49
      • Qingdao, China
        • Boehringer Ingelheim Investigational Site 43
      • Shanghai, 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
      • Shantou, China
        • Boehringer Ingelheim Investigational Site 92
      • Shenyang, 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
      • Shenzhen, China
        • Boehringer Ingelheim Investigational Site 93
      • Shijiazhuang, China
        • Boehringer Ingelheim Investigational Site 2
      • Shijiazhuang, China
        • Boehringer Ingelheim Investigational Site 3
      • Shiyan, China
        • Boehringer Ingelheim Investigational Site 6
      • Suzhou, China
        • Boehringer Ingelheim Investigational Site 51
      • Suzhou, China
        • Boehringer Ingelheim Investigational Site 52
      • Taiyuan, China
        • Boehringer Ingelheim Investigational Site 1
      • Tianjin, China
        • Boehringer Ingelheim Investigational Site 68
      • Tianjin, China
        • Boehringer Ingelheim Investigational Site 69
      • Tianjin, China
        • Boehringer Ingelheim Investigational Site 70
      • Weifang, China
        • Boehringer Ingelheim Investigational Site 41
      • Wenzhou, China
        • Boehringer Ingelheim Investigational Site 33
      • Wuhan, 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
      • Wuxi, China
        • Boehringer Ingelheim Investigational Site 50
      • Xiamen, China
        • Boehringer Ingelheim Investigational Site 34
      • Xian, China
        • Boehringer Ingelheim Investigational Site 102
      • Xian, China
        • Boehringer Ingelheim Investigational Site 103
      • Yantai, China
        • Boehringer Ingelheim Investigational Site 42
      • Zhengzhou, China
        • Boehringer Ingelheim Investigational Site 4
      • Zhengzhou, China
        • Boehringer Ingelheim Investigational Site 5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

3000

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AE/SAE
Time Frame: 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)
Time Frame: 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).
Baseline (Visit 1) and 12 weeks (Visit 3)
The Dosage Related Information of Pramipexole at Baseline
Time Frame: baseline
At enrollment, the distribution of patients in 3 pramipexole dosage categories.
baseline
The Dosage Related Information of Pramipexole at the End of Study
Time Frame: 12 weeks
At the end of study, the distribution of patients in 3 pramipexole dosage categories.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 248.682

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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