a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
|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|
|Primary Completion Date :||February 2012|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361009
Show 103 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|