- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02177318
Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease (COPD)
26. juni 2014 oppdatert av: Boehringer Ingelheim
Drug Use Results Survey of Tiotropium Bromide
To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
3588
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Abashiri, Japan
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Aizubangemachi, Japan
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Aizumisatomachi, Japan
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Aizuwakamatsu, Japan
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Akashi, Japan
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Akita, Japan
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Ako, Japan
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Amagasaki, Japan
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Amakusa, Japan
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Amimachi, Japan
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Anan, Japan
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Anjo, Japan
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Arakawamachi, Japan
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Arao, Japan
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Aritacho, Japan
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Asahikawa, Japan
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Ashikaga, Japan
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Atami, Japan
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Atsugi, Japan
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Awa, Japan
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Ayabe, Japan
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Ayagawacho, Japan
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Ayase, Japan
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Beppu, Japan
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Bibai, Japan
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Bungoohno, Japan
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Chiba, Japan
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Chigasaki, Japan
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Chikusei, Japan
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Chikushino, Japan
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Chitose, Japan
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Date, Japan
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Ebetsu, Japan
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Echizen, Japan
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Emukaecho, Japan
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Engarucho, Japan
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Fuchuu, Japan
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Fuji, Japan
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Fujiidera, Japan
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Fujikawaguchiko, Japan
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Fujinomiya, Japan
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Fukagawa, Japan
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Fukaya, Japan
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Fukuchiyama, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukuroi, Japan
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Fukushima, Japan
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Fukutsu, Japan
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Fukuyama, Japan
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Funabashi, Japan
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Futabamachi, Japan
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Geiseimura, Japan
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Gifu, Japan
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Ginowan, Japan
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Gobo, Japan
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Gosen, Japan
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Gotenba, Japan
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Gyouda, Japan
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Habikino, Japan
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Hachinohe, Japan
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Hachirogatamachi, Japan
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Hagi, Japan
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Hakodate, Japan
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Hakusan, Japan
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Hamada, Japan
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Hamamatsu, Japan
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Handa, Japan
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Hanyuu, Japan
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Hatsukaichi, Japan
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Hayashimacho, Japan
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Higashihiroshima, Japan
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Higashimatsushima, Japan
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Higashiomi, Japan
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Higashiosaka, Japan
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Hikari, Japan
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Himeji, Japan
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Hirakata, Japan
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Hiratsuka, Japan
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Hirosaki, Japan
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Hiroshima, Japan
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Hita, Japan
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Hitachi, Japan
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Hitoyoshi, Japan
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Hofu, Japan
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Iamabari, Japan
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Ibaraki, Japan
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Ibarakimachi, Japan
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Ibigawacho, Japan
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Ibusuki, Japan
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Ichihara, Japan
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Ichinomiya, Japan
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Ichinoseki, Japan
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Iga, Japan
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Iida, Japan
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Iizuka, Japan
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Ikoma, Japan
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Imari, Japan
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Imizu, Japan
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Ina, Japan
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Inazawa, Japan
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Inuyama, Japan
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Isahaya, Japan
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Ise, Japan
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Isehara, Japan
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Ishikari, Japan
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Ishinomaki, Japan
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Itami, Japan
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Itanocho, Japan
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Ito, Japan
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Iwaki, Japan
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Iwakuni, Japan
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Iwamizawa, Japan
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Iwanaicho, Japan
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Iwata, Japan
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Iyo, Japan
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Izu, Japan
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Izumisano, Japan
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Izumo, Japan
- Boehringer Ingelheim Investigational Site
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Izunokuni, Japan
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Jimokujicho, Japan
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Joso, Japan
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Jouetsu, Japan
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Joyo, Japan
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Kaga, Japan
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Kagoshima, Japan
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Kaizuka, Japan
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Kajikicho, Japan
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Kakegawa, Japan
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Kami, Japan
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Kamiamakusa, Japan
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Kamisu, Japan
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Kanazawa, Japan
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Kandamachi, Japan
- Boehringer Ingelheim Investigational Site
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Kanonji, Japan
- Boehringer Ingelheim Investigational Site
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Kasai, Japan
- Boehringer Ingelheim Investigational Site
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Kasama, Japan
- Boehringer Ingelheim Investigational Site
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Kasaoka, Japan
- Boehringer Ingelheim Investigational Site
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Kashihara, Japan
- Boehringer Ingelheim Investigational Site
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Kashima, Japan
- Boehringer Ingelheim Investigational Site
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Kashiwazaki, Japan
- Boehringer Ingelheim Investigational Site
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Kasuga, Japan
- Boehringer Ingelheim Investigational Site
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Kasuigai, Japan
- Boehringer Ingelheim Investigational Site
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Kasukabe, Japan
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Kasuyamachi, Japan
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Kato, Japan
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Katsuyama, Japan
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Kawachinagano, Japan
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Kawagoe, Japan
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Kawaguchi, Japan
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Kawanishimachi, Japan
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Kawasaki, Japan
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Kayano, Japan
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Kazuno, Japan
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Kinkocho, Japan
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Kitakami, Japan
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Kitakyushu, Japan
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Kitami, Japan
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Kobe, Japan
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Kochi, Japan
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Koga, Japan
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Komonocho, Japan
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Konan, Japan
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Koriyama, Japan
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Kouriyama, Japan
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Koushi, Japan
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Koushu, Japan
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Kozakaicho, Japan
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Kudamatsu, Japan
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Kumamoto, Japan
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Kunimimachi, Japan
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Kunisaki, Japan
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Kurashiki, Japan
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Kurayoshi, Japan
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Kure, Japan
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Kurihara, Japan
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Kurume, Japan
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Kushiro, Japan
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Kuwana, Japan
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Kyotango, Japan
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Kyoto, Japan
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Maebashi, Japan
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Marugame, Japan
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Masuda, Japan
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Matsudo, Japan
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Matsue, Japan
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Matsumoto, Japan
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Matsusaka, Japan
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Matsuyama, Japan
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Mibumachi, Japan
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Mihamacho, Japan
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Mihara, Japan
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Minamisatsuma, Japan
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Minamisouma, Japan
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Minamiuonuma, Japan
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Mino, Japan
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Minoh, Japan
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Misasacho, Japan
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Misato, Japan
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Mishima, Japan
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Mito, Japan
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Miyakicho, Japan
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Miyakonojo, Japan
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Miyazaki, Japan
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Miyoshi, Japan
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Mizunami, Japan
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Mobara, Japan
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Moriguchi, Japan
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Morioka, Japan
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Muroran, Japan
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Nabari, Japan
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Nagahama, Japan
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Nagano, Japan
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Nagaoka, Japan
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Nagasaki, Japan
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Nagato, Japan
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Nago, Japan
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Nagoya, Japan
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Naha, Japan
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Nakama, Japan
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Nakashibetsucho, Japan
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Nanao, Japan
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Nankoku, Japan
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Nantan, Japan
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Nara, Japan
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Naruto, Japan
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Nasukarasuyama, Japan
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Neyagawa, Japan
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Nihonmatsu, Japan
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Niigata, Japan
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Niihamashi, Japan
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Nikko, Japan
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Nishiiyo, Japan
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Nishinomiya, Japan
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Nishio, Japan
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Nobeoka, Japan
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Noboribetsu, Japan
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Noda, Japan
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Nomi, Japan
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Noshiro, Japan
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Notocho, Japan
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Numata, Japan
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Numazu, Japan
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Oaraimachi, Japan
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Obama, Japan
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Obihiro, Japan
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Odate, Japan
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Odawara, Japan
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Ogawaramachi, Japan
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Ogi, Japan
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Oita, Japan
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Ojiya, Japan
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Okayama, Japan
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Okinawa, Japan
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Omihachiman, Japan
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Omuta, Japan
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Onomachi, Japan
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Osaka, Japan
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Osakasayama, Japan
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Ota, Japan
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Otake, Japan
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Otaru, Japan
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Otsu, Japan
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Otsumachi, Japan
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Owariasahi, Japan
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Ritto, Japan
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Ryugasaki, Japan
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Sado, Japan
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Saga, Japan
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Sagamihara, Japan
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Saiki, Japan
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Saitama, Japan
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Sakacho, Japan
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Sakai, Japan
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Sakaimachi, Japan
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Sakaiminato, Japan
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Sakata, Japan
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Saku, Japan
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Sanjyo, Japan
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Sanuki, Japan
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Sanyoonoda, Japan
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Sapporo, Japan
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Sasayama, Japan
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Sasebo, Japan
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Satsumasendai, Japan
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Sayama, Japan
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Sendai, Japan
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Sennan, Japan
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Shibetsu, Japan
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Shibukawa, Japan
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Shimada, Japan
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Shimonoseki, Japan
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Shimotsuke, Japan
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Shimotsuma, Japan
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Shingu, Japan
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Shiogama, Japan
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Shirahamacho, Japan
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Shiroishi, Japan
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Shiroishicho, Japan
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Shizuoka, Japan
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Shoocho, Japan
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Shunan, Japan
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Soo, Japan
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Souka, Japan
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Suita, Japan
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Sukagawa, Japan
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Sukumo, Japan
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Sunagawa, Japan
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Susono, Japan
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Suwa, Japan
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Suzuka, Japan
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Tagawa, Japan
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Tainai, Japan
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Takahashi, Japan
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Takamatsu, Japan
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Takaoka, Japan
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Takarazuka, Japan
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Takasago, Japan
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Takashima, Japan
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Takatsuki, Japan
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Taku, Japan
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Tamana, Japan
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Tamano, Japan
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Tanabe, Japan
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Taragimachi, Japan
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Tenri, Japan
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Tokaimura, Japan
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Tokamachi, Japan
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Tokorozawa, Japan
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Tokunoshimacho, Japan
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Tokushima, Japan
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Tokyo Adachi-ku, Japan
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Tokyo Akishima, Japan
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Tokyo Bunkyo-ku, Japan
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Tokyo Chiyoda-ku, Japan
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Tokyo Edogawa-ku, Japan
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Tokyo Hachioji, Japan
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Tokyo Higashimurayama, Japan
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Tokyo Higashiyamato, Japan
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Tokyo Hino, Japan
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Tokyo Itabashi-ku, Japan
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Tokyo Katsushika-ku, Japan
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Tokyo Kiyose, Japan
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Tokyo Komae, Japan
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Tokyo Koto-ku, Japan
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Tokyo Meguro-ku, Japan
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Tokyo Minato-ku, Japan
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Tokyo Nakano-ku, Japan
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Tokyo Nerima-ku, Japan
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Tokyo Nishitokyo, Japan
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Tokyo Ome, Japan
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Tokyo Ota-ku, Japan
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Tokyo Setagaya-ku, Japan
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Tokyo Shibuya-ku, Japan
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Tokyo Shinagawa-ku, Japan
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Tokyo Shinjuku-ku, Japan
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Tokyo Suginami-ku, Japan
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Tokyo Sumida-ku, Japan
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Tokyo Taito-ku, Japan
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Tokyo Toshima-ku, Japan
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Tomakomai, Japan
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Tomigusu, Japan
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Tomioka, Japan
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Tondabayashi, Japan
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Toride, Japan
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Tottori, Japan
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Toyama, Japan
- Boehringer Ingelheim Investigational Site
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Toyohashi, Japan
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japan
- Boehringer Ingelheim Investigational Site
-
Toyooka, Japan
- Boehringer Ingelheim Investigational Site
-
Toyosatocho, Japan
- Boehringer Ingelheim Investigational Site
-
Toyota, Japan
- Boehringer Ingelheim Investigational Site
-
Tsu, Japan
- Boehringer Ingelheim Investigational Site
-
Tsukuba, Japan
- Boehringer Ingelheim Investigational Site
-
Tsurugicho, Japan
- Boehringer Ingelheim Investigational Site
-
Tsuruoka, Japan
- Boehringer Ingelheim Investigational Site
-
Tsushima, Japan
- Boehringer Ingelheim Investigational Site
-
Tsuyama, Japan
- Boehringer Ingelheim Investigational Site
-
Ube, Japan
- Boehringer Ingelheim Investigational Site
-
Uchikocho, Japan
- Boehringer Ingelheim Investigational Site
-
Uchinadamachi, Japan
- Boehringer Ingelheim Investigational Site
-
Uekimachi, Japan
- Boehringer Ingelheim Investigational Site
-
Uji, Japan
- Boehringer Ingelheim Investigational Site
-
Uki, Japan
- Boehringer Ingelheim Investigational Site
-
Unzen, Japan
- Boehringer Ingelheim Investigational Site
-
Urakawacho, Japan
- Boehringer Ingelheim Investigational Site
-
Urasoe, Japan
- Boehringer Ingelheim Investigational Site
-
Urayasu, Japan
- Boehringer Ingelheim Investigational Site
-
Uruma, Japan
- Boehringer Ingelheim Investigational Site
-
Usa, Japan
- Boehringer Ingelheim Investigational Site
-
Usuki, Japan
- Boehringer Ingelheim Investigational Site
-
Utsunomiya, Japan
- Boehringer Ingelheim Investigational Site
-
Wakayama, Japan
- Boehringer Ingelheim Investigational Site
-
Yabu, Japan
- Boehringer Ingelheim Investigational Site
-
Yachimata, Japan
- Boehringer Ingelheim Investigational Site
-
Yachiyo, Japan
- Boehringer Ingelheim Investigational Site
-
Yaizu, Japan
- Boehringer Ingelheim Investigational Site
-
Yakumocho, Japan
- Boehringer Ingelheim Investigational Site
-
Yakushimacho, Japan
- Boehringer Ingelheim Investigational Site
-
Yamaga, Japan
- Boehringer Ingelheim Investigational Site
-
Yamagata, Japan
- Boehringer Ingelheim Investigational Site
-
Yamato, Japan
- Boehringer Ingelheim Investigational Site
-
Yamatotakada, Japan
- Boehringer Ingelheim Investigational Site
-
Yanai, Japan
- Boehringer Ingelheim Investigational Site
-
Yao, Japan
- Boehringer Ingelheim Investigational Site
-
Yatomi, Japan
- Boehringer Ingelheim Investigational Site
-
Yatsushiro, Japan
- Boehringer Ingelheim Investigational Site
-
Yawata, Japan
- Boehringer Ingelheim Investigational Site
-
Yokkaichi, Japan
- Boehringer Ingelheim Investigational Site
-
Yokohama, Japan
- Boehringer Ingelheim Investigational Site
-
Yokosuka, Japan
- Boehringer Ingelheim Investigational Site
-
Yokote, Japan
- Boehringer Ingelheim Investigational Site
-
Yonabarucho, Japan
- Boehringer Ingelheim Investigational Site
-
Yonezawa, Japan
- Boehringer Ingelheim Investigational Site
-
Yorocho, Japan
- Boehringer Ingelheim Investigational Site
-
Yoshinocho, Japan
- Boehringer Ingelheim Investigational Site
-
Yufu, Japan
- Boehringer Ingelheim Investigational Site
-
Yurihonjou, Japan
- Boehringer Ingelheim Investigational Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
COPD patients in daily clinical settings.
Beskrivelse
Inclusion Criteria:
- Patients with COPD
Exclusion Criteria:
-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pasienter med KOLS
|
Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of patients with adverse events
Tidsramme: Up to 4 weeks after start of treatment
|
Up to 4 weeks after start of treatment
|
|
Number of patients with adverse drug reactions
Tidsramme: Up to 4 weeks after start of treatment
|
Up to 4 weeks after start of treatment
|
|
Number of patients with serious adverse events
Tidsramme: Up to 4 weeks after start of treatment
|
Up to 4 weeks after start of treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable
Tidsramme: Up to 4 weeks after start of treatment
|
Up to 4 weeks after start of treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2005
Primær fullføring (Faktiske)
1. september 2007
Datoer for studieregistrering
Først innsendt
31. januar 2008
Først innsendt som oppfylte QC-kriteriene
26. juni 2014
Først lagt ut (Anslag)
27. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Lungesykdommer, obstruktiv
- Lungesykdommer
- Lungesykdom, kronisk obstruktiv
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Parasympatholytika
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge antagonister
- Kolinerge midler
- Antikonvulsiva
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Tiotropiumbromid
- Bromider
Andre studie-ID-numre
- 205.314
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .