- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00615914
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
10 juni 2014 uppdaterad av: Boehringer Ingelheim
Pramipexole Special Survey on Long-Term Use
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
1645
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Agano, Japan
- Boehringer Ingelheim Investigational Site
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Aizuwakamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Akashi, Japan
- Boehringer Ingelheim Investigational Site
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Akita, Japan
- Boehringer Ingelheim Investigational Site
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Asahikawa, Japan
- Boehringer Ingelheim Investigational Site
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Asakura, Japan
- Boehringer Ingelheim Investigational Site
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Ayagawa, Japan
- Boehringer Ingelheim Investigational Site
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Azumino, Japan
- Boehringer Ingelheim Investigational Site
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Bando, Japan
- Boehringer Ingelheim Investigational Site
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Beppu, Japan
- Boehringer Ingelheim Investigational Site
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Bihoro, Japan
- Boehringer Ingelheim Investigational Site
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Chiba, Japan
- Boehringer Ingelheim Investigational Site
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Chikusei, Japan
- Boehringer Ingelheim Investigational Site
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Chuo, Japan
- Boehringer Ingelheim Investigational Site
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Date, Japan
- Boehringer Ingelheim Investigational Site
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Ebetsu, Japan
- Boehringer Ingelheim Investigational Site
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Ebina, Japan
- Boehringer Ingelheim Investigational Site
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Eiheiji, Japan
- Boehringer Ingelheim Investigational Site
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Fuchu, Japan
- Boehringer Ingelheim Investigational Site
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Fuji, Japan
- Boehringer Ingelheim Investigational Site
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Fujieda, Japan
- Boehringer Ingelheim Investigational Site
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Fujinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Fujioka, Japan
- Boehringer Ingelheim Investigational Site
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Fujisawa, Japan
- Boehringer Ingelheim Investigational Site
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Fujiyoshida, Japan
- Boehringer Ingelheim Investigational Site
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Fukaya, Japan
- Boehringer Ingelheim Investigational Site
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Fukui, Japan
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japan
- Boehringer Ingelheim Investigational Site
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Fukushima, Japan
- Boehringer Ingelheim Investigational Site
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Fukuyama, Japan
- Boehringer Ingelheim Investigational Site
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Geisei, Japan
- Boehringer Ingelheim Investigational Site
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Gifu, Japan
- Boehringer Ingelheim Investigational Site
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Ginowan, Japan
- Boehringer Ingelheim Investigational Site
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Hachinohe, Japan
- Boehringer Ingelheim Investigational Site
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Hadano, Japan
- Boehringer Ingelheim Investigational Site
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Haebaru, Japan
- Boehringer Ingelheim Investigational Site
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Hagahama, Japan
- Boehringer Ingelheim Investigational Site
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Hakodate, Japan
- Boehringer Ingelheim Investigational Site
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Hamada, Japan
- Boehringer Ingelheim Investigational Site
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Hamamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Hayashima, Japan
- Boehringer Ingelheim Investigational Site
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Higashimurayama, Japan
- Boehringer Ingelheim Investigational Site
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Higashiosaka, Japan
- Boehringer Ingelheim Investigational Site
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Higashiyamato, Japan
- Boehringer Ingelheim Investigational Site
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Himeji, Japan
- Boehringer Ingelheim Investigational Site
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Hiratsuka, Japan
- Boehringer Ingelheim Investigational Site
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Hirokawa, Japan
- Boehringer Ingelheim Investigational Site
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Hirosaki, Japan
- Boehringer Ingelheim Investigational Site
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Hiroshima, Japan
- Boehringer Ingelheim Investigational Site
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Hita, Japan
- Boehringer Ingelheim Investigational Site
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Hofu, Japan
- Boehringer Ingelheim Investigational Site
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Ibaragi, Japan
- Boehringer Ingelheim Investigational Site
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Ichikikushikino, Japan
- Boehringer Ingelheim Investigational Site
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Ichinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Ichinoseki, Japan
- Boehringer Ingelheim Investigational Site
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Iizuka, Japan
- Boehringer Ingelheim Investigational Site
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Ikeda, Japan
- Boehringer Ingelheim Investigational Site
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Ikoma, Japan
- Boehringer Ingelheim Investigational Site
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Ina, Japan
- Boehringer Ingelheim Investigational Site
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Inazawa, Japan
- Boehringer Ingelheim Investigational Site
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Inba, Japan
- Boehringer Ingelheim Investigational Site
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Inuyama, Japan
- Boehringer Ingelheim Investigational Site
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Isezaki, Japan
- Boehringer Ingelheim Investigational Site
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Itoigawa, Japan
- Boehringer Ingelheim Investigational Site
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Iwaki, Japan
- Boehringer Ingelheim Investigational Site
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Iwata, Japan
- Boehringer Ingelheim Investigational Site
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Joetsu, Japan
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japan
- Boehringer Ingelheim Investigational Site
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Kahoku, Japan
- Boehringer Ingelheim Investigational Site
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Kajiki, Japan
- Boehringer Ingelheim Investigational Site
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Kakegawa, Japan
- Boehringer Ingelheim Investigational Site
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Kakogawa, Japan
- Boehringer Ingelheim Investigational Site
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Kamisu, Japan
- Boehringer Ingelheim Investigational Site
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Kamogawa, Japan
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japan
- Boehringer Ingelheim Investigational Site
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Kannonji, Japan
- Boehringer Ingelheim Investigational Site
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Karatsu, Japan
- Boehringer Ingelheim Investigational Site
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Kashima, Japan
- Boehringer Ingelheim Investigational Site
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Kashiwa, Japan
- Boehringer Ingelheim Investigational Site
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Kashiwazaki, Japan
- Boehringer Ingelheim Investigational Site
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Kasukabe, Japan
- Boehringer Ingelheim Investigational Site
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Kato, Japan
- Boehringer Ingelheim Investigational Site
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Kawagoe, Japan
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japan
- Boehringer Ingelheim Investigational Site
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Kawatana, Japan
- Boehringer Ingelheim Investigational Site
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Kikugawa, Japan
- Boehringer Ingelheim Investigational Site
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Kirishima, Japan
- Boehringer Ingelheim Investigational Site
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Kitakyushu, Japan
- Boehringer Ingelheim Investigational Site
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Kiyose, Japan
- Boehringer Ingelheim Investigational Site
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Kiyotake, Japan
- Boehringer Ingelheim Investigational Site
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Kizugawa, Japan
- Boehringer Ingelheim Investigational Site
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Kobayashi, Japan
- Boehringer Ingelheim Investigational Site
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Kobe, Japan
- Boehringer Ingelheim Investigational Site
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Kochi, Japan
- Boehringer Ingelheim Investigational Site
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Kodaira, Japan
- Boehringer Ingelheim Investigational Site
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Kofu, Japan
- Boehringer Ingelheim Investigational Site
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Koga, Japan
- Boehringer Ingelheim Investigational Site
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Kokubunji, Japan
- Boehringer Ingelheim Investigational Site
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Komae, Japan
- Boehringer Ingelheim Investigational Site
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Komatsu, Japan
- Boehringer Ingelheim Investigational Site
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Komoro, Japan
- Boehringer Ingelheim Investigational Site
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Koriyama, Japan
- Boehringer Ingelheim Investigational Site
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Koshi, Japan
- Boehringer Ingelheim Investigational Site
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Koshigawa, Japan
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japan
- Boehringer Ingelheim Investigational Site
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Kurashiki, Japan
- Boehringer Ingelheim Investigational Site
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Kurayoshi, Japan
- Boehringer Ingelheim Investigational Site
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Kure, Japan
- Boehringer Ingelheim Investigational Site
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Kurume, Japan
- Boehringer Ingelheim Investigational Site
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Kushiro, Japan
- Boehringer Ingelheim Investigational Site
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Kutchan, Japan
- Boehringer Ingelheim Investigational Site
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Kuwana, Japan
- Boehringer Ingelheim Investigational Site
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Kyonan, Japan
- Boehringer Ingelheim Investigational Site
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Kyoto, Japan
- Boehringer Ingelheim Investigational Site
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Maebaru, Japan
- Boehringer Ingelheim Investigational Site
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Maebashi, Japan
- Boehringer Ingelheim Investigational Site
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Maibara, Japan
- Boehringer Ingelheim Investigational Site
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Maizuru, Japan
- Boehringer Ingelheim Investigational Site
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Marugame, Japan
- Boehringer Ingelheim Investigational Site
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Matsuda, Japan
- Boehringer Ingelheim Investigational Site
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Matsudo, Japan
- Boehringer Ingelheim Investigational Site
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Matsue, Japan
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japan
- Boehringer Ingelheim Investigational Site
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Matsuyama, Japan
- Boehringer Ingelheim Investigational Site
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Mibu, Japan
- Boehringer Ingelheim Investigational Site
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Mihara, Japan
- Boehringer Ingelheim Investigational Site
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Miki, Japan
- Boehringer Ingelheim Investigational Site
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Minakami, Japan
- Boehringer Ingelheim Investigational Site
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Minamata, Japan
- Boehringer Ingelheim Investigational Site
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Minobu, Japan
- Boehringer Ingelheim Investigational Site
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Misashino, Japan
- Boehringer Ingelheim Investigational Site
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Mito, Japan
- Boehringer Ingelheim Investigational Site
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Miyaki, Japan
- Boehringer Ingelheim Investigational Site
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Miyakonojo, Japan
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japan
- Boehringer Ingelheim Investigational Site
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Mooka, Japan
- Boehringer Ingelheim Investigational Site
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Moriguchi, Japan
- Boehringer Ingelheim Investigational Site
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Morioka, Japan
- Boehringer Ingelheim Investigational Site
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Moriya, Japan
- Boehringer Ingelheim Investigational Site
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Moriyama, Japan
- Boehringer Ingelheim Investigational Site
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Muroran, Japan
- Boehringer Ingelheim Investigational Site
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Nagakute, Japan
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japan
- Boehringer Ingelheim Investigational Site
-
Nagaokakyo, Japan
- Boehringer Ingelheim Investigational Site
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Nagasaki, Japan
- Boehringer Ingelheim Investigational Site
-
Nagoya, Japan
- Boehringer Ingelheim Investigational Site
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Nangoku, Japan
- Boehringer Ingelheim Investigational Site
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Nara, Japan
- Boehringer Ingelheim Investigational Site
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Narita, Japan
- Boehringer Ingelheim Investigational Site
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Naruto, Japan
- Boehringer Ingelheim Investigational Site
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Nichinan, Japan
- Boehringer Ingelheim Investigational Site
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Niigata, Japan
- Boehringer Ingelheim Investigational Site
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Niihama, Japan
- Boehringer Ingelheim Investigational Site
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Nikko, Japan
- Boehringer Ingelheim Investigational Site
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Nishigo, Japan
- Boehringer Ingelheim Investigational Site
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Nishihara, Japan
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japan
- Boehringer Ingelheim Investigational Site
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Nishio, Japan
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japan
- Boehringer Ingelheim Investigational Site
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Nobeoka, Japan
- Boehringer Ingelheim Investigational Site
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Noboribetsu, Japan
- Boehringer Ingelheim Investigational Site
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Numazu, Japan
- Boehringer Ingelheim Investigational Site
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Obama, Japan
- Boehringer Ingelheim Investigational Site
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Obihiro, Japan
- Boehringer Ingelheim Investigational Site
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Odate, Japan
- Boehringer Ingelheim Investigational Site
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Odawara, Japan
- Boehringer Ingelheim Investigational Site
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Ofunato, Japan
- Boehringer Ingelheim Investigational Site
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Ogaki, Japan
- Boehringer Ingelheim Investigational Site
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Ohzu, Japan
- Boehringer Ingelheim Investigational Site
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Oiso, Japan
- Boehringer Ingelheim Investigational Site
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Oita, Japan
- Boehringer Ingelheim Investigational Site
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Ojiya, Japan
- Boehringer Ingelheim Investigational Site
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Okawa, Japan
- Boehringer Ingelheim Investigational Site
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Okayama, Japan
- Boehringer Ingelheim Investigational Site
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Omaezaki, Japan
- Boehringer Ingelheim Investigational Site
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Omura, Japan
- Boehringer Ingelheim Investigational Site
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Omuta, Japan
- Boehringer Ingelheim Investigational Site
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Onga, Japan
- Boehringer Ingelheim Investigational Site
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Onojo, Japan
- Boehringer Ingelheim Investigational Site
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Onomichi, Japan
- Boehringer Ingelheim Investigational Site
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Osaka, Japan
- Boehringer Ingelheim Investigational Site
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Otsu, Japan
- Boehringer Ingelheim Investigational Site
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Ozu, Japan
- Boehringer Ingelheim Investigational Site
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Sado, Japan
- Boehringer Ingelheim Investigational Site
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Saga, Japan
- Boehringer Ingelheim Investigational Site
-
Sagamihara, Japan
- Boehringer Ingelheim Investigational Site
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Saitama, Japan
- Boehringer Ingelheim Investigational Site
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Sakai, Japan
- Boehringer Ingelheim Investigational Site
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Sakaide, Japan
- Boehringer Ingelheim Investigational Site
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Sakata, Japan
- Boehringer Ingelheim Investigational Site
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Saku, Japan
- Boehringer Ingelheim Investigational Site
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Sanjo, Japan
- Boehringer Ingelheim Investigational Site
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Sano, Japan
- Boehringer Ingelheim Investigational Site
-
Sanyoonoda, Japan
- Boehringer Ingelheim Investigational Site
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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
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Tokoname, Japan
- Boehringer Ingelheim Investigational Site
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Tokushima, Japan
- Boehringer Ingelheim Investigational Site
-
Tokyo Adachi-ku, Japan
- Boehringer Ingelheim Investigational Site
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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
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Tokyo Katsushika-ku, Japan
- Boehringer Ingelheim Investigational Site
-
Tokyo Kita-ku, Japan
- Boehringer Ingelheim Investigational Site
-
Tokyo Meguro-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Minayo-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Nakano-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japan
- Boehringer Ingelheim Investigational Site
-
Tokyo Shinagawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjuku-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Suginami-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tomakomai, Japan
- Boehringer Ingelheim Investigational Site
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Tomiai, Japan
- Boehringer Ingelheim Investigational Site
-
Tondabayashi, Japan
- Boehringer Ingelheim Investigational Site
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Toon, Japan
- Boehringer Ingelheim Investigational Site
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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
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Yokkaichi, Japan
- Boehringer Ingelheim Investigational Site
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Yokohama, Japan
- Boehringer Ingelheim Investigational Site
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Yokote, Japan
- Boehringer Ingelheim Investigational Site
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Yoro, Japan
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japan
- Boehringer Ingelheim Investigational Site
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Yufu, Japan
- Boehringer Ingelheim Investigational Site
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Zama, Japan
- Boehringer Ingelheim Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Parkinson's disease patients in daily clinical settings
Beskrivning
Inclusion Criteria:
Patients with Parkinson's disease
Exclusion Criteria:
Patients should have been treated according to the Japanese insert slip
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Tidsram: during 18 months
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Global Impression of Improvement
Tidsram: 18 months
|
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
|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Tidsram: Baseline and at 18 months (or at the time of discontinuation)
|
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)
|
|
Change From Baseline in Modified Hoehn & Yahr Rating Scale
Tidsram: Baseline and at 18 months (or at the time of discontinuation)
|
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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2004
Primärt slutförande (Faktisk)
1 mars 2009
Studieregistreringsdatum
Först inskickad
31 januari 2008
Först inskickad som uppfyllde QC-kriterierna
13 februari 2008
Första postat (Uppskatta)
14 februari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 juli 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 248.547
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .