- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00614575
Survey on PD Patients With Depressive Symptoms
BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.
i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Akashi, Japán
- Boehringer Ingelheim Investigational Site
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Akita, Japán
- Boehringer Ingelheim Investigational Site 1
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Akita, Japán
- Boehringer Ingelheim Investigational Site 2
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Asahikawa, Japán
- Boehringer Ingelheim Investigational Site
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Ashikaga, Japán
- Boehringer Ingelheim Investigational Site
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Awaji, Japán
- Boehringer Ingelheim Investigational Site
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Chitose, Japán
- Boehringer Ingelheim Investigational Site
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Chuo, Japán
- Boehringer Ingelheim Investigational Site
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Fuchu, Japán
- Boehringer Ingelheim Investigational Site 1
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Fuchu, Japán
- Boehringer Ingelheim Investigational Site 2
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Fuefuki, Japán
- Boehringer Ingelheim Investigational Site
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Fuehuki, Japán
- Boehringer Ingelheim Investigational Site
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Fujioka, Japán
- Boehringer Ingelheim Investigational Site
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Fujisaki, Japán
- Boehringer Ingelheim Investigational Site
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Fujisawa, Japán
- Boehringer Ingelheim Investigational Site
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Fukaya, Japán
- Boehringer Ingelheim Investigational Site
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Fukuoka, Japán
- Boehringer Ingelheim Investigational Site 1
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Fukuoka, Japán
- Boehringer Ingelheim Investigational Site 2
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Fukuoka, Japán
- Boehringer Ingelheim Investigational Site 3
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Fukuoka, Japán
- Boehringer Ingelheim Investigational Site 4
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Fukuoka, Japán
- Boehringer Ingelheim Investigational Site 5
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Fukushima, Japán
- Boehringer Ingelheim Investigational Site 1
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Fukushima, Japán
- Boehringer Ingelheim Investigational Site 2
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Funabashi, Japán
- Boehringer Ingelheim Investigational Site
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Gifu, Japán
- Boehringer Ingelheim Investigational Site 1
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Gifu, Japán
- Boehringer Ingelheim Investigational Site 2
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Habikino, Japán
- Boehringer Ingelheim Investigational Site
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Hachioji, Japán
- Boehringer Ingelheim Investigational Site
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Hamamatsu, Japán
- Boehringer Ingelheim Investigational Site 1
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Hamamatsu, Japán
- Boehringer Ingelheim Investigational Site 2
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Hamamatsu, Japán
- Boehringer Ingelheim Investigational Site 3
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Hamamatsu, Japán
- Boehringer Ingelheim Investigational Site 4
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Hamamatsu, Japán
- Boehringer Ingelheim Investigational Site 5
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Hanamaki, Japán
- Boehringer Ingelheim Investigational Site
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Hayashima, Japán
- Boehringer Ingelheim Investigational Site
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Higashiosaka, Japán
- Boehringer Ingelheim Investigational Site 1
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Higashiosaka, Japán
- Boehringer Ingelheim Investigational Site 2
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Himeji, Japán
- Boehringer Ingelheim Investigational Site
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Hirakata, Japán
- Boehringer Ingelheim Investigational Site
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Hirishima, Japán
- Boehringer Ingelheim Investigational Site
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Hirosaki, Japán
- Boehringer Ingelheim Investigational Site
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Ibaragi, Japán
- Boehringer Ingelheim Investigational Site
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Iizuka, Japán
- Boehringer Ingelheim Investigational Site
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Inag, Japán
- Boehringer Ingelheim Investigational Site
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Irima, Japán
- Boehringer Ingelheim Investigational Site
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Isahaya, Japán
- Boehringer Ingelheim Investigational Site
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Iwaki, Japán
- Boehringer Ingelheim Investigational Site
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Iwamizawa, Japán
- Boehringer Ingelheim Investigational Site
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Iwata, Japán
- Boehringer Ingelheim Investigational Site
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Jyoetsu, Japán
- Boehringer Ingelheim Investigational Site 1
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Jyoetsu, Japán
- Boehringer Ingelheim Investigational Site 2
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Jyoyo, Japán
- Boehringer Ingelheim Investigational Site
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Kagoshima, Japán
- Boehringer Ingelheim Investigational Site 1
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Kagoshima, Japán
- Boehringer Ingelheim Investigational Site 2
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Kagoshima, Japán
- Boehringer Ingelheim Investigational Site 3
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Kahoku, Japán
- Boehringer Ingelheim Investigational Site
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Kamakura, Japán
- Boehringer Ingelheim Investigational Site
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Kanazawa, Japán
- Boehringer Ingelheim Investigational Site 1
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Kanazawa, Japán
- Boehringer Ingelheim Investigational Site 2
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Kanoya, Japán
- Boehringer Ingelheim Investigational Site 1
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Kanoya, Japán
- Boehringer Ingelheim Investigational Site 2
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Kashihara, Japán
- Boehringer Ingelheim Investigational Site 1
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Kashihara, Japán
- Boehringer Ingelheim Investigational Site 2
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Kasuga, Japán
- Boehringer Ingelheim Investigational Site
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Kawagchi, Japán
- Boehringer Ingelheim Investigational Site
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Kawaguchi, Japán
- Boehringer Ingelheim Investigational Site
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Kawasaki, Japán
- Boehringer Ingelheim Investigational Site 1
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Kawasaki, Japán
- Boehringer Ingelheim Investigational Site 2
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Kitakami, Japán
- Boehringer Ingelheim Investigational Site
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Kiyose, Japán
- Boehringer Ingelheim Investigational Site 1
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Kiyose, Japán
- Boehringer Ingelheim Investigational Site 2
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Kodaira, Japán
- Boehringer Ingelheim Investigational Site
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Kofu, Japán
- Boehringer Ingelheim Investigational Site
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Koga, Japán
- Boehringer Ingelheim Investigational Site
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Komae, Japán
- Boehringer Ingelheim Investigational Site
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Komatsu, Japán
- Boehringer Ingelheim Investigational Site
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Komatsushima, Japán
- Boehringer Ingelheim Investigational Site
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Koriyama, Japán
- Boehringer Ingelheim Investigational Site 1
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Koriyama, Japán
- Boehringer Ingelheim Investigational Site 2
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Koshigaya, Japán
- Boehringer Ingelheim Investigational Site
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Kumamoto, Japán
- Boehringer Ingelheim Investigational Site 1
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Kumamoto, Japán
- Boehringer Ingelheim Investigational Site 2
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Kumamoto, Japán
- Boehringer Ingelheim Investigational Site 3
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Kure, Japán
- Boehringer Ingelheim Investigational Site
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Kusatsu, Japán
- Boehringer Ingelheim Investigational Site
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Kyoto, Japán
- Boehringer Ingelheim Investigational Site 1
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Kyoto, Japán
- Boehringer Ingelheim Investigational Site 2
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Kyoto, Japán
- Boehringer Ingelheim Investigational Site 3
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Kyoto, Japán
- Boehringer Ingelheim Investigational Site 4
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Maebashi, Japán
- Boehringer Ingelheim Investigational Site
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Matsudo, Japán
- Boehringer Ingelheim Investigational Site
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Matsumoto, Japán
- Boehringer Ingelheim Investigational Site
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Mibu, Japán
- Boehringer Ingelheim Investigational Site
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Mihara, Japán
- Boehringer Ingelheim Investigational Site
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Mihoro, Japán
- Boehringer Ingelheim Investigational Site
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Miriyama, Japán
- Boehringer Ingelheim Investigational Site
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Misato, Japán
- Boehringer Ingelheim Investigational Site
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Miyako, Japán
- Boehringer Ingelheim Investigational Site
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Miyazaki, Japán
- Boehringer Ingelheim Investigational Site 1
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Miyazaki, Japán
- Boehringer Ingelheim Investigational Site 2
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Moriguchi, Japán
- Boehringer Ingelheim Investigational Site
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Morioka, Japán
- Boehringer Ingelheim Investigational Site 1
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Morioka, Japán
- Boehringer Ingelheim Investigational Site 2
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Moriya, Japán
- Boehringer Ingelheim Investigational Site
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Musashino, Japán
- Boehringer Ingelheim Investigational Site
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Nagano, Japán
- Boehringer Ingelheim Investigational Site
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Nagaoka, Japán
- Boehringer Ingelheim Investigational Site
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Nagaokakyo, Japán
- Boehringer Ingelheim Investigational Site
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Nagoya, Japán
- Boehringer Ingelheim Investigational Site 1
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Nagoya, Japán
- Boehringer Ingelheim Investigational Site 2
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Nagoya, Japán
- Boehringer Ingelheim Investigational Site 3
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Nagoya, Japán
- Boehringer Ingelheim Investigational Site 4
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Nara, Japán
- Boehringer Ingelheim Investigational Site 1
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Nara, Japán
- Boehringer Ingelheim Investigational Site 2
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Narashino, Japán
- Boehringer Ingelheim Investigational Site
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Narita, Japán
- Boehringer Ingelheim Investigational Site
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Naruto, Japán
- Boehringer Ingelheim Investigational Site
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Nasushiobara, Japán
- Boehringer Ingelheim Investigational Site
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Nichinan, Japán
- Boehringer Ingelheim Investigational Site
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Ninohe, Japán
- Boehringer Ingelheim Investigational Site
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Nishinomiya, Japán
- Boehringer Ingelheim Investigational Site
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Nishitokyo, Japán
- Boehringer Ingelheim Investigational Site
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Ogaki, Japán
- Boehringer Ingelheim Investigational Site
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Oiso, Japán
- Boehringer Ingelheim Investigational Site
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Oita, Japán
- Boehringer Ingelheim Investigational Site 1
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Oita, Japán
- Boehringer Ingelheim Investigational Site 2
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Oita, Japán
- Boehringer Ingelheim Investigational Site 3
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Okaya, Japán
- Boehringer Ingelheim Investigational Site
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Okayama, Japán
- Boehringer Ingelheim Investigational Site 1
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Okayama, Japán
- Boehringer Ingelheim Investigational Site 2
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Okazaki, Japán
- Boehringer Ingelheim Investigational Site
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Okinawa, Japán
- Boehringer Ingelheim Investigational Site
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Omura, Japán
- Boehringer Ingelheim Investigational Site
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Omuta, Japán
- Boehringer Ingelheim Investigational Site
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Onojyo, Japán
- Boehringer Ingelheim Investigational Site
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 1
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 2
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 3
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 4
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 5
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Osaka, Japán
- Boehringer Ingelheim Investigational Site 6
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Ota, Japán
- Boehringer Ingelheim Investigational Site
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Otake, Japán
- Boehringer Ingelheim Investigational Site
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Otsu, Japán
- Boehringer Ingelheim Investigational Site
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Ryugasaki, Japán
- Boehringer Ingelheim Investigational Site
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Saeki, Japán
- Boehringer Ingelheim Investigational Site
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Saga, Japán
- Boehringer Ingelheim Investigational Site
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Sagamihara, Japán
- Boehringer Ingelheim Investigational Site 1
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Sagamihara, Japán
- Boehringer Ingelheim Investigational Site 2
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Sagamihara, Japán
- Boehringer Ingelheim Investigational Site 3
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Saijyo, Japán
- Boehringer Ingelheim Investigational Site
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Saitama, Japán
- Boehringer Ingelheim Investigational Site
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Sakai, Japán
- Boehringer Ingelheim Investigational Site 1
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Sakai, Japán
- Boehringer Ingelheim Investigational Site 2
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Sapporo, Japán
- Boehringer Ingelheim Investigational Site 3
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Sapporo, Japán
- Boehringer Ingelheim Investigational Site 4
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Sapporo, Japán
- Boehringer Ingelheim Investigational Site 5
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Sapporo, Japán
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Sapporo, Japán
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Sapporo, Japán
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Sapporo, Japán
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Sapporo, Japán
- Boehringer Ingelheim Investigational Site 1
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Sapporo, Japán
- Boehringer Ingelheim Investigational Site 2
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Sekigahara, Japán
- Boehringer Ingelheim Investigational Site
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Sendai, Japán
- Boehringer Ingelheim Investigational Site 1
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Sendai, Japán
- Boehringer Ingelheim Investigational Site 2
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Shimoda, Japán
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japán
- Boehringer Ingelheim Investigational Site 1
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Shimotsuke, Japán
- Boehringer Ingelheim Investigational Site 2
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Shinngu, Japán
- Boehringer Ingelheim Investigational Site
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Shiroishi, Japán
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japán
- Boehringer Ingelheim Investigational Site 1
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Shizuoka, Japán
- Boehringer Ingelheim Investigational Site 2
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Showajima, Japán
- Boehringer Ingelheim Investigational Site
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Suita, Japán
- Boehringer Ingelheim Investigational Site 1
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Suita, Japán
- Boehringer Ingelheim Investigational Site 2
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Susono, Japán
- Boehringer Ingelheim Investigational Site
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Suzuka, Japán
- Boehringer Ingelheim Investigational Site
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Takaoka, Japán
- Boehringer Ingelheim Investigational Site 1
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Takaoka, Japán
- Boehringer Ingelheim Investigational Site 2
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Takatsuki, Japán
- Boehringer Ingelheim Investigational Site
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Tarimizu, Japán
- Boehringer Ingelheim Investigational Site
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Togitsu, Japán
- Boehringer Ingelheim Investigational Site
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Tokoname, Japán
- Boehringer Ingelheim Investigational Site
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Tokushima, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Arakawa-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Chuo-ku, Japán
- Boehringer Ingelheim Investigational Site 1
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Tokyo Chuo-ku, Japán
- Boehringer Ingelheim Investigational Site 2
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Tokyo Daito-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Koto-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Meguro-ku, Japán
- Boehringer Ingelheim Investigational Site 1
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Tokyo Meguro-ku, Japán
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japán
- Boehringer Ingelheim Investigational Site 1
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Tokyo Minato-ku, Japán
- Boehringer Ingelheim Investigational Site 2
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Tokyo Minato-ku, Japán
- Boehringer Ingelheim Investigational Site 3
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Tokyo Nakano-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Nerima-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Ota-ku, Japán
- Boehringer Ingelheim Investigational Site 1
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Tokyo Ota-ku, Japán
- Boehringer Ingelheim Investigational Site 2
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Tokyo Setagaya, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Setagaya-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Shibuya-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Shinagawa-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Shinjyuku-ku, Japán
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku, Japán
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku, Japán
- Boehringer Ingelheim Investigational Site 3
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Tokyo Sibuya-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo Toshima-ku, Japán
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Tokyo-Edogawa-ku, Japán
- Boehringer Ingelheim Investigational Site
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Tokyo-Itabashi-ku, Japán
- Boehringer Ingelheim Investigational Site
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Toride, Japán
- Boehringer Ingelheim Investigational Site
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Tosu, Japán
- Boehringer Ingelheim Investigational Site
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Toyama, Japán
- Boehringer Ingelheim Investigational Site 1
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Toyama, Japán
- Boehringer Ingelheim Investigational Site 2
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Toyama, Japán
- Boehringer Ingelheim Investigational Site 3
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Toyohashi, Japán
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japán
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japán
- Boehringer Ingelheim Investigational Site
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Ube, Japán
- Boehringer Ingelheim Investigational Site
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Uchinada, Japán
- Boehringer Ingelheim Investigational Site
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Ueda, Japán
- Boehringer Ingelheim Investigational Site
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Ushiku, Japán
- Boehringer Ingelheim Investigational Site
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Utsunomiya, Japán
- Boehringer Ingelheim Investigational Site 1
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Utsunomiya, Japán
- Boehringer Ingelheim Investigational Site 2
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Wakayama, Japán
- Boehringer Ingelheim Investigational Site
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Yachiyo, Japán
- Boehringer Ingelheim Investigational Site 1
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Yachiyo, Japán
- Boehringer Ingelheim Investigational Site 2
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Yachiyo, Japán
- Boehringer Ingelheim Investigational Site 3
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Yamanashi, Japán
- Boehringer Ingelheim Investigational Site
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Yanago, Japán
- Boehringer Ingelheim Investigational Site
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Yoichi, Japán
- Boehringer Ingelheim Investigational Site
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Yokohama, Japán
- Boehringer Ingelheim Investigational Site 1
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Yokohama, Japán
- Boehringer Ingelheim Investigational Site 2
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Yokohama, Japán
- Boehringer Ingelheim Investigational Site 3
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Yokohama, Japán
- Boehringer Ingelheim Investigational Site 4
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Yokosuka, Japán
- Boehringer Ingelheim Investigational Site
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Yoshinogawa, Japán
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion criteria:
**PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.
Exclusion criteria:
- PD patients with the past history of suicidal attempt, suicidal ideation or tendency
- PD patients with suicidal ideation
- PD patients with the past history of suicidal tendency
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Időkeret: for 12 weeks
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The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms.
The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.
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for 12 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Clinical Global Impression of Improvement
Időkeret: for 12 weeks after initiation of the treatment
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Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
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for 12 weeks after initiation of the treatment
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Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Időkeret: Baseline and after 12 weeks (or at the time of discontinuation)
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Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction).
The total score ranged from 0 to 56.
A negative change in the Part III total score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
Időkeret: Baseline and after 12 weeks (or at the time of discontinuation)
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The degree of severity in depressive state are scored between 0-63 in BDI.
A decrease in the score means improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Időkeret: Baseline and after 12 weeks (or at the time of discontinuation)
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Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression.
Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent).
A higher score indicates more severe depression symptoms.
A negative change in the item 3 score indicates improvement.
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Baseline and after 12 weeks (or at the time of discontinuation)
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Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
Időkeret: After 12 weeks or at the time of discontinuation
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This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease.
The scale ranges from 0 (No signs) to 5 (Bedridden).
A negative change in the Yahr rating scale indicates improvement.
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After 12 weeks or at the time of discontinuation
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 248.635
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .