a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
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 Design:||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|
- Incidence of AE/SAE [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]At the end of study, the distribution of patients in 3 pramipexole dosage categories.
|Study Start Date:||May 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361009
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|