Special Survey on PD Patients With Renal Dysfunction

Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00613756

Enrollment

107

Registered

2008-02-13

Start date

2004-02-29

Completion date

Unknown

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	up to 12 weeks
Incidence of adverse drug reactions (ADRs	up to 12 weeks
Incidence of serious adverse events (SAEs)	up to 12 weeks

Secondary

Measure	Time frame
Modified Hoehn & Yahr rating scale	change from baseline to week 12
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

Countries

Japan

Outcome results