Survey on PD Patients With Depressive Symptoms
perjantai 1. elokuuta 2014 päivittänyt: Boehringer Ingelheim
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
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
1089
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Akashi, Japani
- Boehringer Ingelheim Investigational Site
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Akita, Japani
- Boehringer Ingelheim Investigational Site 1
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Akita, Japani
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Asahikawa, Japani
- Boehringer Ingelheim Investigational Site
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Ashikaga, Japani
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Awaji, Japani
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Chitose, Japani
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Chuo, Japani
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Fuchu, Japani
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Fuchu, Japani
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Fuefuki, Japani
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Fuehuki, Japani
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Fujioka, Japani
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Fujisaki, Japani
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Fujisawa, Japani
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Fukaya, Japani
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Fukuoka, Japani
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Fukuoka, Japani
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Fukuoka, Japani
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Fukuoka, Japani
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Fukuoka, Japani
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Fukushima, Japani
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Fukushima, Japani
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Funabashi, Japani
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Gifu, Japani
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Gifu, Japani
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Habikino, Japani
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Hachioji, Japani
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Hamamatsu, Japani
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Hamamatsu, Japani
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Hamamatsu, Japani
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Hamamatsu, Japani
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Hamamatsu, Japani
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Hanamaki, Japani
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Hayashima, Japani
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Higashiosaka, Japani
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Higashiosaka, Japani
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Himeji, Japani
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Hirakata, Japani
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Hirishima, Japani
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Hirosaki, Japani
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Ibaragi, Japani
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Iizuka, Japani
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Inag, Japani
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Irima, Japani
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Isahaya, Japani
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Iwaki, Japani
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Iwamizawa, Japani
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Iwata, Japani
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Jyoetsu, Japani
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Jyoetsu, Japani
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Jyoyo, Japani
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Kagoshima, Japani
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Kagoshima, Japani
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Kagoshima, Japani
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Kahoku, Japani
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Kamakura, Japani
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Kanazawa, Japani
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Kanazawa, Japani
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Kanoya, Japani
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Kanoya, Japani
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Kashihara, Japani
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Kashihara, Japani
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Kasuga, Japani
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Kawagchi, Japani
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Kawaguchi, Japani
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Kawasaki, Japani
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Kawasaki, Japani
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Kitakami, Japani
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Kiyose, Japani
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Kiyose, Japani
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Kodaira, Japani
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Kofu, Japani
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Koga, Japani
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Komae, Japani
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Komatsu, Japani
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Komatsushima, Japani
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Koriyama, Japani
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Koriyama, Japani
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Koshigaya, Japani
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Kumamoto, Japani
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Kumamoto, Japani
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Kumamoto, Japani
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Kure, Japani
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Kusatsu, Japani
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Kyoto, Japani
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Kyoto, Japani
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Kyoto, Japani
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Kyoto, Japani
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Maebashi, Japani
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Matsudo, Japani
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Matsumoto, Japani
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Mibu, Japani
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Mihara, Japani
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Mihoro, Japani
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Miriyama, Japani
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Misato, Japani
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Miyako, Japani
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Miyazaki, Japani
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Miyazaki, Japani
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Moriguchi, Japani
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Morioka, Japani
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Morioka, Japani
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Moriya, Japani
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Musashino, Japani
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Nagano, Japani
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Nagaoka, Japani
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Nagaokakyo, Japani
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Nagoya, Japani
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Nagoya, Japani
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Nagoya, Japani
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Nagoya, Japani
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Nara, Japani
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Nara, Japani
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Narashino, Japani
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Narita, Japani
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Naruto, Japani
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Nasushiobara, Japani
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Nichinan, Japani
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Ninohe, Japani
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Nishinomiya, Japani
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Nishitokyo, Japani
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Ogaki, Japani
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Oiso, Japani
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Oita, Japani
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Oita, Japani
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Oita, Japani
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Okaya, Japani
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Okayama, Japani
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Okayama, Japani
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Okazaki, Japani
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Okinawa, Japani
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Omura, Japani
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Omuta, Japani
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Onojyo, Japani
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Osaka, Japani
- Boehringer Ingelheim Investigational Site 1
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Osaka, Japani
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Osaka, Japani
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Osaka, Japani
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Osaka, Japani
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Osaka, Japani
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Ota, Japani
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Otake, Japani
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Otsu, Japani
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Ryugasaki, Japani
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Saeki, Japani
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Saga, Japani
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Sagamihara, Japani
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Sagamihara, Japani
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Sagamihara, Japani
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Saijyo, Japani
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Saitama, Japani
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Sakai, Japani
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Sakai, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sapporo, Japani
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Sekigahara, Japani
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Sendai, Japani
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Sendai, Japani
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Shimoda, Japani
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Shimotsuke, Japani
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Shimotsuke, Japani
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Shinngu, Japani
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Shiroishi, Japani
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Shizuoka, Japani
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Shizuoka, Japani
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Showajima, Japani
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Suita, Japani
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Suita, Japani
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Susono, Japani
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Suzuka, Japani
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Takaoka, Japani
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Takaoka, Japani
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Takatsuki, Japani
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Tarimizu, Japani
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Togitsu, Japani
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Tokoname, Japani
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Tokushima, Japani
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Tokyo Arakawa-ku, Japani
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Tokyo Bunkyo-ku, Japani
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Tokyo Chuo-ku, Japani
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Tokyo Chuo-ku, Japani
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Tokyo Daito-ku, Japani
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Tokyo Koto-ku, Japani
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Tokyo Meguro-ku, Japani
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Tokyo Meguro-ku, Japani
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Tokyo Minato-ku, Japani
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Tokyo Minato-ku, Japani
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Tokyo Minato-ku, Japani
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Tokyo Nakano-ku, Japani
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Tokyo Nerima-ku, Japani
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Tokyo Ota-ku, Japani
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Tokyo Ota-ku, Japani
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Tokyo Setagaya, Japani
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Tokyo Setagaya-ku, Japani
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Tokyo Shibuya-ku, Japani
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Tokyo Shinagawa-ku, Japani
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Tokyo Shinjyuku-ku, Japani
- Boehringer Ingelheim Investigational Site 1
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Tokyo Shinjyuku-ku, Japani
- Boehringer Ingelheim Investigational Site 2
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Tokyo Shinjyuku-ku, Japani
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Tokyo Sibuya-ku, Japani
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Tokyo Toshima-ku, Japani
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Tokyo-Edogawa-ku, Japani
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Tokyo-Itabashi-ku, Japani
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Toride, Japani
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Tosu, Japani
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Toyama, Japani
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Toyama, Japani
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Toyama, Japani
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Toyohashi, Japani
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Toyokawa, Japani
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Toyonaka, Japani
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Ube, Japani
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Uchinada, Japani
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Ueda, Japani
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Ushiku, Japani
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Utsunomiya, Japani
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Utsunomiya, Japani
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Wakayama, Japani
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Yachiyo, Japani
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Yachiyo, Japani
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Yachiyo, Japani
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Yamanashi, Japani
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Yanago, Japani
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Yoichi, Japani
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Yokohama, Japani
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Yokohama, Japani
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Yokohama, Japani
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Yokohama, Japani
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Yokosuka, Japani
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Yoshinogawa, Japani
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
20 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
PD patients with depressive symptoms
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Clinical Global Impression of Improvement
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. tammikuuta 2007
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. elokuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 31. tammikuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 12. helmikuuta 2008
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 13. helmikuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 6. elokuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 1. elokuuta 2014
Viimeksi vahvistettu
Perjantai 1. elokuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 248.635
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .