a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
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|ClinicalTrials.gov Identifier: NCT01361009|
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : August 30, 2013
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment|
|Parkinson Disease||Drug: pramipexole|
|Study Type :||Observational|
|Actual Enrollment :||2017 participants|
|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 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
It's a open-label, non-intervention,observation post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
as prescibed by the investigator
- 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.
- 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).
- The Dosage Related Information of Pramipexole at Baseline [ Time Frame: baseline ]At enrollment, the distribution of patients in 3 pramipexole dosage categories.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361009
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|