Special Survey on PD Patients With Renal Dysfunction
Completed
- Conditions
- Parkinson Disease
- Registration Number
- NCT00613756
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Inclusion Criteria
Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =<70mL/min or whose renal dysfunction was determined by the physician
Exclusion Criteria
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs up to 12 weeks Incidence of serious adverse events (SAEs) up to 12 weeks Incidence of adverse events up to 12 weeks
- Secondary Outcome Measures
Name Time Method Unified Parkinson's Disease Rating Scale (UPDRS) part III total score change from baseline to week 12 Physician's overall judgement by medical interview into 4 grades (5 categories) week 12 Modified Hoehn & Yahr rating scale change from baseline to week 12
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇯🇵Yufu, Japan