- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615914
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole
June 10, 2014 updated by: 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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1645
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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
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Nagaokakyo, Japan
- Boehringer Ingelheim Investigational Site
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Nagasaki, Japan
- Boehringer Ingelheim Investigational Site
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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
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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
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Sanyoonoda, Japan
- Boehringer Ingelheim Investigational Site
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Sapporo, Japan
- Boehringer Ingelheim Investigational Site
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Sasebo, Japan
- Boehringer Ingelheim Investigational Site
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Seijo, Japan
- Boehringer Ingelheim Investigational Site
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Sendai, Japan
- Boehringer Ingelheim Investigational Site
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Shimabara, Japan
- Boehringer Ingelheim Investigational Site
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Shimonoseki, Japan
- Boehringer Ingelheim Investigational Site
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Shimotsuke, Japan
- Boehringer Ingelheim Investigational Site
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Shingu, Japan
- Boehringer Ingelheim Investigational Site
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Shinshiro, Japan
- Boehringer Ingelheim Investigational Site
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Shizuoka, Japan
- Boehringer Ingelheim Investigational Site
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Shunan, Japan
- Boehringer Ingelheim Investigational Site
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Soo, Japan
- Boehringer Ingelheim Investigational Site
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Suita, Japan
- Boehringer Ingelheim Investigational Site
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Tajimi, Japan
- Boehringer Ingelheim Investigational Site
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Takamatsu, Japan
- Boehringer Ingelheim Investigational Site
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Takanabe, Japan
- Boehringer Ingelheim Investigational Site
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Takaoka, Japan
- Boehringer Ingelheim Investigational Site
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Takasago, Japan
- Boehringer Ingelheim Investigational Site
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Takasaki, Japan
- Boehringer Ingelheim Investigational Site
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Takatsuki, Japan
- Boehringer Ingelheim Investigational Site
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Takehara, Japan
- Boehringer Ingelheim Investigational Site
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Toda, Japan
- Boehringer Ingelheim Investigational Site
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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
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Tokyo Adachi-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Bunkyo-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Chiyoda-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Edogawa-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Itabashi-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Katsushika-ku, Japan
- Boehringer Ingelheim Investigational Site
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Tokyo Kita-ku, Japan
- Boehringer Ingelheim Investigational Site
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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
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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
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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
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Toyama, Japan
- Boehringer Ingelheim Investigational Site
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Toyoake, Japan
- Boehringer Ingelheim Investigational Site
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Toyokawa, Japan
- Boehringer Ingelheim Investigational Site
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Toyonaka, Japan
- Boehringer Ingelheim Investigational Site
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Toyooka, Japan
- Boehringer Ingelheim Investigational Site
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Tsu, Japan
- Boehringer Ingelheim Investigational Site
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Tsubata, Japan
- Boehringer Ingelheim Investigational Site
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Tsuchiura, Japan
- Boehringer Ingelheim Investigational Site
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Tsukuba, Japan
- Boehringer Ingelheim Investigational Site
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Tsuruoka, Japan
- Boehringer Ingelheim Investigational Site
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Uchinada, Japan
- Boehringer Ingelheim Investigational Site
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Ueda, Japan
- Boehringer Ingelheim Investigational Site
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Uji, Japan
- Boehringer Ingelheim Investigational Site
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Ujo, Japan
- Boehringer Ingelheim Investigational Site
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Urayasu, Japan
- Boehringer Ingelheim Investigational Site
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Uruma, Japan
- Boehringer Ingelheim Investigational Site
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Utsunomiya, Japan
- Boehringer Ingelheim Investigational Site
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Wakayama, Japan
- Boehringer Ingelheim Investigational Site
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Yamagata, Japan
- Boehringer Ingelheim Investigational Site
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Yamaguchi, Japan
- Boehringer Ingelheim Investigational Site
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Yamamoto, Japan
- Boehringer Ingelheim Investigational Site
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Yanai, Japan
- Boehringer Ingelheim Investigational Site
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Yao, Japan
- Boehringer Ingelheim Investigational Site
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Yashiro, Japan
- Boehringer Ingelheim Investigational Site
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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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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parkinson's disease patients in daily clinical settings
Description
Inclusion Criteria:
Patients with Parkinson's disease
Exclusion Criteria:
Patients should have been treated according to the Japanese insert slip
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Global Impression of Improvement
Time Frame: 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
|
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Time Frame: 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)
|
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Change From Baseline in Modified Hoehn & Yahr Rating Scale
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
January 31, 2008
First Submitted That Met QC Criteria
February 13, 2008
First Posted (Estimate)
February 14, 2008
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
June 10, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248.547
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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