Clinical trial NCT00613756: Special Survey on PD Patients With Renal Dysfunction
Official title: Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic PD with renal dysfunction from Primary Care setting.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to 12 weeks
measure: Incidence of adverse drug reactions (ADRs
timeFrame: up to 12 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Modified Hoehn & Yahr rating scale
timeFrame: change from baseline to week 12
measure: Unified Parkinson's Disease Rating Scale (UPDRS) part III total score
timeFrame: change from baseline to week 12
measure: Physician's overall judgement by medical interview into 4 grades (5 categories)
timeFrame: week 12
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Azumino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Chuo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Eiheiji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fujinomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fujisaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fuji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Gifu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hachioji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hamamatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Himeji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ichinoseki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iida
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Inazawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ina
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Isehara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Isezaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iwamizawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kagoshima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kajiki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kanoya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kashiwazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawagoe
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komae
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koriyama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koshigaya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kurashiki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Maebashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Marugame
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsudo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mito
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miyazaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Miyoshi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mooka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Moroyama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagahama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagakute
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nanao
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nangoku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Narita
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nishinomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ogaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Oita
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okayama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okinawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Onga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Onojo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Oshu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sado
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sagamihara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sanjo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sekigahara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shimotsuke
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shingu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shunan
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Suita
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Takasago
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Takatsuki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Togitsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Adachi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Bunkyo-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Chiyoda-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Itabashi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Meguro-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Ota-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Setagaya-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shibuya-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shinjuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Suginami-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toride
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Toyoake
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tsukuba
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Uki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Wakayama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yamaguchi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yokosuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yonago
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yoshinogawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yufu
country: Japan
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: