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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00615914
Other study ID # 248.547
Secondary ID
Status Completed
Phase N/A
First received January 31, 2008
Last updated June 10, 2014
Start date February 2004

Study information

Verified date June 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.


Recruitment information / eligibility

Status Completed
Enrollment 1645
Est. completion date
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Boehringer Ingelheim Investigational Site Agano
Japan Boehringer Ingelheim Investigational Site Aizuwakamatsu
Japan Boehringer Ingelheim Investigational Site Akashi
Japan Boehringer Ingelheim Investigational Site Akita
Japan Boehringer Ingelheim Investigational Site Asahikawa
Japan Boehringer Ingelheim Investigational Site Asakura
Japan Boehringer Ingelheim Investigational Site Ayagawa
Japan Boehringer Ingelheim Investigational Site Azumino
Japan Boehringer Ingelheim Investigational Site Bando
Japan Boehringer Ingelheim Investigational Site Beppu
Japan Boehringer Ingelheim Investigational Site Bihoro
Japan Boehringer Ingelheim Investigational Site Chiba
Japan Boehringer Ingelheim Investigational Site Chikusei
Japan Boehringer Ingelheim Investigational Site Chuo
Japan Boehringer Ingelheim Investigational Site Date
Japan Boehringer Ingelheim Investigational Site Ebetsu
Japan Boehringer Ingelheim Investigational Site Ebina
Japan Boehringer Ingelheim Investigational Site Eiheiji
Japan Boehringer Ingelheim Investigational Site Fuchu
Japan Boehringer Ingelheim Investigational Site Fuji
Japan Boehringer Ingelheim Investigational Site Fujieda
Japan Boehringer Ingelheim Investigational Site Fujinomiya
Japan Boehringer Ingelheim Investigational Site Fujioka
Japan Boehringer Ingelheim Investigational Site Fujisawa
Japan Boehringer Ingelheim Investigational Site Fujiyoshida
Japan Boehringer Ingelheim Investigational Site Fukaya
Japan Boehringer Ingelheim Investigational Site Fukui
Japan Boehringer Ingelheim Investigational Site Fukuoka
Japan Boehringer Ingelheim Investigational Site Fukushima
Japan Boehringer Ingelheim Investigational Site Fukuyama
Japan Boehringer Ingelheim Investigational Site Geisei
Japan Boehringer Ingelheim Investigational Site Gifu
Japan Boehringer Ingelheim Investigational Site Ginowan
Japan Boehringer Ingelheim Investigational Site Hachinohe
Japan Boehringer Ingelheim Investigational Site Hadano
Japan Boehringer Ingelheim Investigational Site Haebaru
Japan Boehringer Ingelheim Investigational Site Hagahama
Japan Boehringer Ingelheim Investigational Site Hakodate
Japan Boehringer Ingelheim Investigational Site Hamada
Japan Boehringer Ingelheim Investigational Site Hamamatsu
Japan Boehringer Ingelheim Investigational Site Hayashima
Japan Boehringer Ingelheim Investigational Site Higashimurayama
Japan Boehringer Ingelheim Investigational Site Higashiosaka
Japan Boehringer Ingelheim Investigational Site Higashiyamato
Japan Boehringer Ingelheim Investigational Site Himeji
Japan Boehringer Ingelheim Investigational Site Hiratsuka
Japan Boehringer Ingelheim Investigational Site Hirokawa
Japan Boehringer Ingelheim Investigational Site Hirosaki
Japan Boehringer Ingelheim Investigational Site Hiroshima
Japan Boehringer Ingelheim Investigational Site Hita
Japan Boehringer Ingelheim Investigational Site Hofu
Japan Boehringer Ingelheim Investigational Site Ibaragi
Japan Boehringer Ingelheim Investigational Site Ichikikushikino
Japan Boehringer Ingelheim Investigational Site Ichinomiya
Japan Boehringer Ingelheim Investigational Site Ichinoseki
Japan Boehringer Ingelheim Investigational Site Iizuka
Japan Boehringer Ingelheim Investigational Site Ikeda
Japan Boehringer Ingelheim Investigational Site Ikoma
Japan Boehringer Ingelheim Investigational Site Ina
Japan Boehringer Ingelheim Investigational Site Inazawa
Japan Boehringer Ingelheim Investigational Site Inba
Japan Boehringer Ingelheim Investigational Site Inuyama
Japan Boehringer Ingelheim Investigational Site Isezaki
Japan Boehringer Ingelheim Investigational Site Itoigawa
Japan Boehringer Ingelheim Investigational Site Iwaki
Japan Boehringer Ingelheim Investigational Site Iwata
Japan Boehringer Ingelheim Investigational Site Joetsu
Japan Boehringer Ingelheim Investigational Site Kagoshima
Japan Boehringer Ingelheim Investigational Site Kahoku
Japan Boehringer Ingelheim Investigational Site Kajiki
Japan Boehringer Ingelheim Investigational Site Kakegawa
Japan Boehringer Ingelheim Investigational Site Kakogawa
Japan Boehringer Ingelheim Investigational Site Kamisu
Japan Boehringer Ingelheim Investigational Site Kamogawa
Japan Boehringer Ingelheim Investigational Site Kanazawa
Japan Boehringer Ingelheim Investigational Site Kannonji
Japan Boehringer Ingelheim Investigational Site Karatsu
Japan Boehringer Ingelheim Investigational Site Kashima
Japan Boehringer Ingelheim Investigational Site Kashiwa
Japan Boehringer Ingelheim Investigational Site Kashiwazaki
Japan Boehringer Ingelheim Investigational Site Kasukabe
Japan Boehringer Ingelheim Investigational Site Kato
Japan Boehringer Ingelheim Investigational Site Kawagoe
Japan Boehringer Ingelheim Investigational Site Kawasaki
Japan Boehringer Ingelheim Investigational Site Kawatana
Japan Boehringer Ingelheim Investigational Site Kikugawa
Japan Boehringer Ingelheim Investigational Site Kirishima
Japan Boehringer Ingelheim Investigational Site Kitakyushu
Japan Boehringer Ingelheim Investigational Site Kiyose
Japan Boehringer Ingelheim Investigational Site Kiyotake
Japan Boehringer Ingelheim Investigational Site Kizugawa
Japan Boehringer Ingelheim Investigational Site Kobayashi
Japan Boehringer Ingelheim Investigational Site Kobe
Japan Boehringer Ingelheim Investigational Site Kochi
Japan Boehringer Ingelheim Investigational Site Kodaira
Japan Boehringer Ingelheim Investigational Site Kofu
Japan Boehringer Ingelheim Investigational Site Koga
Japan Boehringer Ingelheim Investigational Site Kokubunji
Japan Boehringer Ingelheim Investigational Site Komae
Japan Boehringer Ingelheim Investigational Site Komatsu
Japan Boehringer Ingelheim Investigational Site Komoro
Japan Boehringer Ingelheim Investigational Site Koriyama
Japan Boehringer Ingelheim Investigational Site Koshi
Japan Boehringer Ingelheim Investigational Site Koshigawa
Japan Boehringer Ingelheim Investigational Site Kumamoto
Japan Boehringer Ingelheim Investigational Site Kurashiki
Japan Boehringer Ingelheim Investigational Site Kurayoshi
Japan Boehringer Ingelheim Investigational Site Kure
Japan Boehringer Ingelheim Investigational Site Kurume
Japan Boehringer Ingelheim Investigational Site Kushiro
Japan Boehringer Ingelheim Investigational Site Kutchan
Japan Boehringer Ingelheim Investigational Site Kuwana
Japan Boehringer Ingelheim Investigational Site Kyonan
Japan Boehringer Ingelheim Investigational Site Kyoto
Japan Boehringer Ingelheim Investigational Site Maebaru
Japan Boehringer Ingelheim Investigational Site Maebashi
Japan Boehringer Ingelheim Investigational Site Maibara
Japan Boehringer Ingelheim Investigational Site Maizuru
Japan Boehringer Ingelheim Investigational Site Marugame
Japan Boehringer Ingelheim Investigational Site Matsuda
Japan Boehringer Ingelheim Investigational Site Matsudo
Japan Boehringer Ingelheim Investigational Site Matsue
Japan Boehringer Ingelheim Investigational Site Matsumoto
Japan Boehringer Ingelheim Investigational Site Matsuyama
Japan Boehringer Ingelheim Investigational Site Mibu
Japan Boehringer Ingelheim Investigational Site Mihara
Japan Boehringer Ingelheim Investigational Site Miki
Japan Boehringer Ingelheim Investigational Site Minakami
Japan Boehringer Ingelheim Investigational Site Minamata
Japan Boehringer Ingelheim Investigational Site Minobu
Japan Boehringer Ingelheim Investigational Site Misashino
Japan Boehringer Ingelheim Investigational Site Mito
Japan Boehringer Ingelheim Investigational Site Miyaki
Japan Boehringer Ingelheim Investigational Site Miyakonojo
Japan Boehringer Ingelheim Investigational Site Miyazaki
Japan Boehringer Ingelheim Investigational Site Mooka
Japan Boehringer Ingelheim Investigational Site Moriguchi
Japan Boehringer Ingelheim Investigational Site Morioka
Japan Boehringer Ingelheim Investigational Site Moriya
Japan Boehringer Ingelheim Investigational Site Moriyama
Japan Boehringer Ingelheim Investigational Site Muroran
Japan Boehringer Ingelheim Investigational Site Nagakute
Japan Boehringer Ingelheim Investigational Site Nagaoka
Japan Boehringer Ingelheim Investigational Site Nagaokakyo
Japan Boehringer Ingelheim Investigational Site Nagasaki
Japan Boehringer Ingelheim Investigational Site Nagoya
Japan Boehringer Ingelheim Investigational Site Nangoku
Japan Boehringer Ingelheim Investigational Site Nara
Japan Boehringer Ingelheim Investigational Site Narita
Japan Boehringer Ingelheim Investigational Site Naruto
Japan Boehringer Ingelheim Investigational Site Nichinan
Japan Boehringer Ingelheim Investigational Site Niigata
Japan Boehringer Ingelheim Investigational Site Niihama
Japan Boehringer Ingelheim Investigational Site Nikko
Japan Boehringer Ingelheim Investigational Site Nishigo
Japan Boehringer Ingelheim Investigational Site Nishihara
Japan Boehringer Ingelheim Investigational Site Nishinomiya
Japan Boehringer Ingelheim Investigational Site Nishio
Japan Boehringer Ingelheim Investigational Site Nishitokyo
Japan Boehringer Ingelheim Investigational Site Nobeoka
Japan Boehringer Ingelheim Investigational Site Noboribetsu
Japan Boehringer Ingelheim Investigational Site Numazu
Japan Boehringer Ingelheim Investigational Site Obama
Japan Boehringer Ingelheim Investigational Site Obihiro
Japan Boehringer Ingelheim Investigational Site Odate
Japan Boehringer Ingelheim Investigational Site Odawara
Japan Boehringer Ingelheim Investigational Site Ofunato
Japan Boehringer Ingelheim Investigational Site Ogaki
Japan Boehringer Ingelheim Investigational Site Ohzu
Japan Boehringer Ingelheim Investigational Site Oiso
Japan Boehringer Ingelheim Investigational Site Oita
Japan Boehringer Ingelheim Investigational Site Ojiya
Japan Boehringer Ingelheim Investigational Site Okawa
Japan Boehringer Ingelheim Investigational Site Okayama
Japan Boehringer Ingelheim Investigational Site Omaezaki
Japan Boehringer Ingelheim Investigational Site Omura
Japan Boehringer Ingelheim Investigational Site Omuta
Japan Boehringer Ingelheim Investigational Site Onga
Japan Boehringer Ingelheim Investigational Site Onojo
Japan Boehringer Ingelheim Investigational Site Onomichi
Japan Boehringer Ingelheim Investigational Site Osaka
Japan Boehringer Ingelheim Investigational Site Otsu
Japan Boehringer Ingelheim Investigational Site Ozu
Japan Boehringer Ingelheim Investigational Site Sado
Japan Boehringer Ingelheim Investigational Site Saga
Japan Boehringer Ingelheim Investigational Site Sagamihara
Japan Boehringer Ingelheim Investigational Site Saitama
Japan Boehringer Ingelheim Investigational Site Sakai
Japan Boehringer Ingelheim Investigational Site Sakaide
Japan Boehringer Ingelheim Investigational Site Sakata
Japan Boehringer Ingelheim Investigational Site Saku
Japan Boehringer Ingelheim Investigational Site Sanjo
Japan Boehringer Ingelheim Investigational Site Sano
Japan Boehringer Ingelheim Investigational Site Sanyoonoda
Japan Boehringer Ingelheim Investigational Site Sapporo
Japan Boehringer Ingelheim Investigational Site Sasebo
Japan Boehringer Ingelheim Investigational Site Seijo
Japan Boehringer Ingelheim Investigational Site Sendai
Japan Boehringer Ingelheim Investigational Site Shimabara
Japan Boehringer Ingelheim Investigational Site Shimonoseki
Japan Boehringer Ingelheim Investigational Site Shimotsuke
Japan Boehringer Ingelheim Investigational Site Shingu
Japan Boehringer Ingelheim Investigational Site Shinshiro
Japan Boehringer Ingelheim Investigational Site Shizuoka
Japan Boehringer Ingelheim Investigational Site Shunan
Japan Boehringer Ingelheim Investigational Site Soo
Japan Boehringer Ingelheim Investigational Site Suita
Japan Boehringer Ingelheim Investigational Site Tajimi
Japan Boehringer Ingelheim Investigational Site Takamatsu
Japan Boehringer Ingelheim Investigational Site Takanabe
Japan Boehringer Ingelheim Investigational Site Takaoka
Japan Boehringer Ingelheim Investigational Site Takasago
Japan Boehringer Ingelheim Investigational Site Takasaki
Japan Boehringer Ingelheim Investigational Site Takatsuki
Japan Boehringer Ingelheim Investigational Site Takehara
Japan Boehringer Ingelheim Investigational Site Toda
Japan Boehringer Ingelheim Investigational Site Togitsu
Japan Boehringer Ingelheim Investigational Site Tokoname
Japan Boehringer Ingelheim Investigational Site Tokushima
Japan Boehringer Ingelheim Investigational Site Tokyo Adachi-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Bunkyo-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Chiyoda-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Edogawa-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Itabashi-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Katsushika-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Kita-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Meguro-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Minayo-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Nakano-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Nerima-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Ota-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Setagaya-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Shinagawa-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Shinjuku-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Suginami-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Toshima-ku
Japan Boehringer Ingelheim Investigational Site Tomakomai
Japan Boehringer Ingelheim Investigational Site Tomiai
Japan Boehringer Ingelheim Investigational Site Tondabayashi
Japan Boehringer Ingelheim Investigational Site Toon
Japan Boehringer Ingelheim Investigational Site Toride
Japan Boehringer Ingelheim Investigational Site Toyama
Japan Boehringer Ingelheim Investigational Site Toyoake
Japan Boehringer Ingelheim Investigational Site Toyokawa
Japan Boehringer Ingelheim Investigational Site Toyonaka
Japan Boehringer Ingelheim Investigational Site Toyooka
Japan Boehringer Ingelheim Investigational Site Tsu
Japan Boehringer Ingelheim Investigational Site Tsubata
Japan Boehringer Ingelheim Investigational Site Tsuchiura
Japan Boehringer Ingelheim Investigational Site Tsukuba
Japan Boehringer Ingelheim Investigational Site Tsuruoka
Japan Boehringer Ingelheim Investigational Site Uchinada
Japan Boehringer Ingelheim Investigational Site Ueda
Japan Boehringer Ingelheim Investigational Site Uji
Japan Boehringer Ingelheim Investigational Site Ujo
Japan Boehringer Ingelheim Investigational Site Urayasu
Japan Boehringer Ingelheim Investigational Site Uruma
Japan Boehringer Ingelheim Investigational Site Utsunomiya
Japan Boehringer Ingelheim Investigational Site Wakayama
Japan Boehringer Ingelheim Investigational Site Yamagata
Japan Boehringer Ingelheim Investigational Site Yamaguchi
Japan Boehringer Ingelheim Investigational Site Yamamoto
Japan Boehringer Ingelheim Investigational Site Yanai
Japan Boehringer Ingelheim Investigational Site Yao
Japan Boehringer Ingelheim Investigational Site Yashiro
Japan Boehringer Ingelheim Investigational Site Yazu
Japan Boehringer Ingelheim Investigational Site Yokkaichi
Japan Boehringer Ingelheim Investigational Site Yokohama
Japan Boehringer Ingelheim Investigational Site Yokote
Japan Boehringer Ingelheim Investigational Site Yoro
Japan Boehringer Ingelheim Investigational Site Yoshinogawa
Japan Boehringer Ingelheim Investigational Site Yufu
Japan Boehringer Ingelheim Investigational Site Zama

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation. during 18 months No
Secondary Clinical Global Impression of Improvement Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). 18 months No
Secondary Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement. Baseline and at 18 months (or at the time of discontinuation) No
Secondary Change From Baseline in Modified Hoehn & Yahr Rating Scale A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst). Baseline and at 18 months (or at the time of discontinuation) No
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