N/A
N=2,017
a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01361009 ↗Enrolled (actual)
2,017
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Incidence of AE/SAE — 5.16 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- pramipexole (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of AE/SAE |
5.16 | — |
| SECONDARY Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study) |
3.53; 2.48 | — |
| SECONDARY The Dosage Related Information of Pramipexole at Baseline |
84.93; 12.99; 2.08 | — |
| SECONDARY The Dosage Related Information of Pramipexole at the End of Study |
33.56; 46.16; 20.28 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Diagnosed as idiopathic PD (Parkinson' disease) according to UK brain bank criteria
- Age: from 30 to 75 years old
- Stage I-IV of revised Hoehn-Yahr standards
- With current use of pramipexole
- Informed consent signed by every subject
Exclusion criteria
- Diagnosis of Parkinson¿s syndrome
- Current use of psychotolytic medications
- Allergic to pramipexole or any other ingredient of pramipexole
- Female patients in pregnancy and lactation
- 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
Data sourced from ClinicalTrials.gov (NCT01361009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.