Survey on PD Patients With Depressive Symptoms

NCT ID: NCT00614575

Last Updated: 2014-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BI-Sifrol® Tablets (Pramipexole)

BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Akashi, , Japan

Site Status

Boehringer Ingelheim Investigational Site 1

Akita, , Japan

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Boehringer Ingelheim Investigational Site 2

Akita, , Japan

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Boehringer Ingelheim Investigational Site

Asahikawa, , Japan

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Boehringer Ingelheim Investigational Site

Ashikaga, , Japan

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Boehringer Ingelheim Investigational Site

Awaji, , Japan

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Boehringer Ingelheim Investigational Site

Chitose, , Japan

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Boehringer Ingelheim Investigational Site

Chūō, , Japan

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Boehringer Ingelheim Investigational Site 1

Fuchū, , Japan

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Boehringer Ingelheim Investigational Site 2

Fuchū, , Japan

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Boehringer Ingelheim Investigational Site

Fuefuki, , Japan

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Boehringer Ingelheim Investigational Site

Fuehuki, , Japan

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Boehringer Ingelheim Investigational Site

Fujioka, , Japan

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Boehringer Ingelheim Investigational Site

Fujisaki, , Japan

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Boehringer Ingelheim Investigational Site

Fujisawa, , Japan

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Boehringer Ingelheim Investigational Site

Fukaya, , Japan

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Boehringer Ingelheim Investigational Site 1

Fukuoka, , Japan

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Boehringer Ingelheim Investigational Site 2

Fukuoka, , Japan

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Boehringer Ingelheim Investigational Site 3

Fukuoka, , Japan

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Boehringer Ingelheim Investigational Site 4

Fukuoka, , Japan

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Boehringer Ingelheim Investigational Site 5

Fukuoka, , Japan

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Boehringer Ingelheim Investigational Site 1

Fukushima, , Japan

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Boehringer Ingelheim Investigational Site 2

Fukushima, , Japan

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Boehringer Ingelheim Investigational Site

Funabashi, , Japan

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Boehringer Ingelheim Investigational Site 1

Gifu, , Japan

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Boehringer Ingelheim Investigational Site 2

Gifu, , Japan

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Boehringer Ingelheim Investigational Site

Habikino, , Japan

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Boehringer Ingelheim Investigational Site

Hachiōji, , Japan

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Boehringer Ingelheim Investigational Site 1

Hamamatsu, , Japan

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Boehringer Ingelheim Investigational Site 2

Hamamatsu, , Japan

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Boehringer Ingelheim Investigational Site 3

Hamamatsu, , Japan

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Boehringer Ingelheim Investigational Site 4

Hamamatsu, , Japan

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Boehringer Ingelheim Investigational Site 5

Hamamatsu, , Japan

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Boehringer Ingelheim Investigational Site

Hanamaki, , Japan

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Boehringer Ingelheim Investigational Site

Hayashima, , Japan

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Boehringer Ingelheim Investigational Site 1

Higashiosaka, , Japan

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Boehringer Ingelheim Investigational Site 2

Higashiosaka, , Japan

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Boehringer Ingelheim Investigational Site

Himeji, , Japan

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Boehringer Ingelheim Investigational Site

Hirakata, , Japan

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Boehringer Ingelheim Investigational Site

Hirishima, , Japan

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Boehringer Ingelheim Investigational Site

Hirosaki, , Japan

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Boehringer Ingelheim Investigational Site

Ibaraki, , Japan

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Boehringer Ingelheim Investigational Site

Iizuka, , Japan

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Boehringer Ingelheim Investigational Site

Inag, , Japan

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Boehringer Ingelheim Investigational Site

Irima, , Japan

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Boehringer Ingelheim Investigational Site

Isahaya, , Japan

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Boehringer Ingelheim Investigational Site

Iwaki, , Japan

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Boehringer Ingelheim Investigational Site

Iwamizawa, , Japan

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Boehringer Ingelheim Investigational Site

Iwata, , Japan

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Boehringer Ingelheim Investigational Site 1

Jyoetsu, , Japan

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Boehringer Ingelheim Investigational Site 2

Jyoetsu, , Japan

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Boehringer Ingelheim Investigational Site

Jyoyo, , Japan

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Boehringer Ingelheim Investigational Site 1

Kagoshima, , Japan

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Boehringer Ingelheim Investigational Site 2

Kagoshima, , Japan

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Boehringer Ingelheim Investigational Site 3

Kagoshima, , Japan

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Boehringer Ingelheim Investigational Site

Kahoku, , Japan

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Boehringer Ingelheim Investigational Site

Kamakura, , Japan

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Boehringer Ingelheim Investigational Site 1

Kanazawa, , Japan

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Boehringer Ingelheim Investigational Site 2

Kanazawa, , Japan

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Boehringer Ingelheim Investigational Site 1

Kanoya, , Japan

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Boehringer Ingelheim Investigational Site 2

Kanoya, , Japan

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Boehringer Ingelheim Investigational Site 1

Kashihara, , Japan

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Boehringer Ingelheim Investigational Site 2

Kashihara, , Japan

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Boehringer Ingelheim Investigational Site

Kasuga, , Japan

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Boehringer Ingelheim Investigational Site

Kawagchi, , Japan

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Boehringer Ingelheim Investigational Site

Kawaguchi, , Japan

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Boehringer Ingelheim Investigational Site 1

Kawasaki, , Japan

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Boehringer Ingelheim Investigational Site 2

Kawasaki, , Japan

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Boehringer Ingelheim Investigational Site

Kitakami, , Japan

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Boehringer Ingelheim Investigational Site 1

Kiyose, , Japan

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Boehringer Ingelheim Investigational Site 2

Kiyose, , Japan

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Boehringer Ingelheim Investigational Site

Kodaira, , Japan

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Boehringer Ingelheim Investigational Site

Kofu, , Japan

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Boehringer Ingelheim Investigational Site

Koga, , Japan

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Boehringer Ingelheim Investigational Site

Komae, , Japan

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Komatsu, , Japan

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Boehringer Ingelheim Investigational Site

Komatsushima, , Japan

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Boehringer Ingelheim Investigational Site

Koshigaya, , Japan

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Boehringer Ingelheim Investigational Site 1

Kōriyama, , Japan

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Boehringer Ingelheim Investigational Site 2

Kōriyama, , Japan

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Boehringer Ingelheim Investigational Site

Kōtari, , Japan

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Boehringer Ingelheim Investigational Site 1

Kumamoto, , Japan

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Boehringer Ingelheim Investigational Site 2

Kumamoto, , Japan

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Boehringer Ingelheim Investigational Site 3

Kumamoto, , Japan

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Boehringer Ingelheim Investigational Site

Kure, , Japan

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Boehringer Ingelheim Investigational Site

Kusatsu, , Japan

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Boehringer Ingelheim Investigational Site 1

Kyoto, , Japan

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Boehringer Ingelheim Investigational Site 2

Kyoto, , Japan

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Boehringer Ingelheim Investigational Site 3

Kyoto, , Japan

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Boehringer Ingelheim Investigational Site 4

Kyoto, , Japan

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Boehringer Ingelheim Investigational Site

Maebashi, , Japan

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Matsudo, , Japan

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Boehringer Ingelheim Investigational Site

Matsumoto, , Japan

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Boehringer Ingelheim Investigational Site

Mibu, , Japan

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Mihara, , Japan

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Mihoro, , Japan

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Miriyama, , Japan

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Boehringer Ingelheim Investigational Site

Misato, , Japan

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Boehringer Ingelheim Investigational Site

Miyako, , Japan

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Boehringer Ingelheim Investigational Site 1

Miyazaki, , Japan

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Boehringer Ingelheim Investigational Site 2

Miyazaki, , Japan

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Boehringer Ingelheim Investigational Site

Moriguchi, , Japan

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Boehringer Ingelheim Investigational Site 1

Morioka, , Japan

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Boehringer Ingelheim Investigational Site 2

Morioka, , Japan

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Boehringer Ingelheim Investigational Site

Moriya, , Japan

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Boehringer Ingelheim Investigational Site

Mukai-awagasaki, , Japan

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Boehringer Ingelheim Investigational Site

Musashino, , Japan

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Boehringer Ingelheim Investigational Site

Nagano, , Japan

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Boehringer Ingelheim Investigational Site

Nagaoka, , Japan

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Boehringer Ingelheim Investigational Site 1

Nagoya, , Japan

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Boehringer Ingelheim Investigational Site 2

Nagoya, , Japan

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Boehringer Ingelheim Investigational Site 3

Nagoya, , Japan

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Boehringer Ingelheim Investigational Site 4

Nagoya, , Japan

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Boehringer Ingelheim Investigational Site 1

Nara, , Japan

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Boehringer Ingelheim Investigational Site 2

Nara, , Japan

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Boehringer Ingelheim Investigational Site

Narashino, , Japan

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Boehringer Ingelheim Investigational Site

Narita, , Japan

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Boehringer Ingelheim Investigational Site

Narutō, , Japan

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Boehringer Ingelheim Investigational Site

Nasushiobara, , Japan

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Boehringer Ingelheim Investigational Site

Nichinan, , Japan

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Boehringer Ingelheim Investigational Site

Ninohe, , Japan

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Boehringer Ingelheim Investigational Site

Nishinomiya, , Japan

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Boehringer Ingelheim Investigational Site

Nishitōkyō, , Japan

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Boehringer Ingelheim Investigational Site

Okaya, , Japan

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Boehringer Ingelheim Investigational Site 1

Okayama, , Japan

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Boehringer Ingelheim Investigational Site 2

Okayama, , Japan

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Boehringer Ingelheim Investigational Site

Okazaki, , Japan

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Boehringer Ingelheim Investigational Site

Okinawa, , Japan

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Boehringer Ingelheim Investigational Site

Omuta, , Japan

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Boehringer Ingelheim Investigational Site 1

Osaka, , Japan

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Boehringer Ingelheim Investigational Site 2

Osaka, , Japan

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Boehringer Ingelheim Investigational Site 3

Osaka, , Japan

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Boehringer Ingelheim Investigational Site 4

Osaka, , Japan

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Boehringer Ingelheim Investigational Site 5

Osaka, , Japan

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Boehringer Ingelheim Investigational Site 6

Osaka, , Japan

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Boehringer Ingelheim Investigational Site

Ōgaki, , Japan

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Boehringer Ingelheim Investigational Site

Ōiso, , Japan

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Boehringer Ingelheim Investigational Site 1

Ōita, , Japan

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Boehringer Ingelheim Investigational Site 2

Ōita, , Japan

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Boehringer Ingelheim Investigational Site 3

Ōita, , Japan

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Boehringer Ingelheim Investigational Site

Ōmura, , Japan

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Boehringer Ingelheim Investigational Site

Ōnojō, , Japan

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Boehringer Ingelheim Investigational Site

Ōta-ku, , Japan

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Boehringer Ingelheim Investigational Site

Ōtake, , Japan

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Boehringer Ingelheim Investigational Site

Ōtsu, , Japan

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Boehringer Ingelheim Investigational Site

Ryūgasaki, , Japan

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Boehringer Ingelheim Investigational Site

Saeki, , Japan

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Boehringer Ingelheim Investigational Site

Saga, , Japan

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Boehringer Ingelheim Investigational Site 1

Sagamihara, , Japan

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Boehringer Ingelheim Investigational Site 2

Sagamihara, , Japan

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Boehringer Ingelheim Investigational Site 3

Sagamihara, , Japan

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Boehringer Ingelheim Investigational Site

Saijyo, , Japan

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Boehringer Ingelheim Investigational Site

Saitama, , Japan

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Boehringer Ingelheim Investigational Site 1

Sakai, , Japan

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Boehringer Ingelheim Investigational Site 2

Sakai, , Japan

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Boehringer Ingelheim Investigational Site 1

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 2

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 3

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 4

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 5

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 6

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 7

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 8

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site 9

Sapporo, , Japan

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Boehringer Ingelheim Investigational Site

Sekigahara, , Japan

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Boehringer Ingelheim Investigational Site 1

Sendai, , Japan

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Boehringer Ingelheim Investigational Site 2

Sendai, , Japan

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Boehringer Ingelheim Investigational Site

Shimoda, , Japan

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Boehringer Ingelheim Investigational Site 1

Shimotsuke, , Japan

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Boehringer Ingelheim Investigational Site 2

Shimotsuke, , Japan

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Boehringer Ingelheim Investigational Site

Shinngu, , Japan

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Boehringer Ingelheim Investigational Site

Shiroishi, , Japan

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Boehringer Ingelheim Investigational Site 1

Shizuoka, , Japan

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Boehringer Ingelheim Investigational Site 2

Shizuoka, , Japan

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Boehringer Ingelheim Investigational Site

Shōwajima, , Japan

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Boehringer Ingelheim Investigational Site 1

Suita, , Japan

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Boehringer Ingelheim Investigational Site 2

Suita, , Japan

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Boehringer Ingelheim Investigational Site

Susono, , Japan

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Boehringer Ingelheim Investigational Site

Suzuka, , Japan

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Boehringer Ingelheim Investigational Site 1

Takaoka, , Japan

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Boehringer Ingelheim Investigational Site 2

Takaoka, , Japan

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Boehringer Ingelheim Investigational Site

Takatsuki, , Japan

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Boehringer Ingelheim Investigational Site

Tarimizu, , Japan

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Boehringer Ingelheim Investigational Site

Togitsu, , Japan

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Boehringer Ingelheim Investigational Site

Tokoname, , Japan

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Boehringer Ingelheim Investigational Site

Tokushima, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Arakawa-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Bunkyo-ku, , Japan

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Boehringer Ingelheim Investigational Site 1

Tokyo Chuo-ku, , Japan

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Boehringer Ingelheim Investigational Site 2

Tokyo Chuo-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Daito-ku, , Japan

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Tokyo Koto-ku, , Japan

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Tokyo Meguro-ku, , Japan

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Tokyo Meguro-ku, , Japan

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Boehringer Ingelheim Investigational Site 1

Tokyo Minato-ku, , Japan

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Boehringer Ingelheim Investigational Site 2

Tokyo Minato-ku, , Japan

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Boehringer Ingelheim Investigational Site 3

Tokyo Minato-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Nakano-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Nerima-ku, , Japan

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Boehringer Ingelheim Investigational Site 1

Tokyo Ota-ku, , Japan

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Boehringer Ingelheim Investigational Site 2

Tokyo Ota-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Setagaya-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Setagaya, , Japan

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Tokyo Shibuya-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Shinagawa-ku, , Japan

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Boehringer Ingelheim Investigational Site 1

Tokyo Shinjyuku-ku, , Japan

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Boehringer Ingelheim Investigational Site 2

Tokyo Shinjyuku-ku, , Japan

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Tokyo Shinjyuku-ku, , Japan

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Tokyo Sibuya-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo Toshima-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo-Edogawa-ku, , Japan

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Boehringer Ingelheim Investigational Site

Tokyo-Itabashi-ku, , Japan

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Boehringer Ingelheim Investigational Site

Toride, , Japan

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Boehringer Ingelheim Investigational Site

Tosu, , Japan

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Boehringer Ingelheim Investigational Site 1

Toyama, , Japan

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Boehringer Ingelheim Investigational Site 2

Toyama, , Japan

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Boehringer Ingelheim Investigational Site 3

Toyama, , Japan

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Toyohashi, , Japan

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Toyokawa, , Japan

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Toyonaka, , Japan

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Boehringer Ingelheim Investigational Site

Ube, , Japan

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Ueda, , Japan

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Boehringer Ingelheim Investigational Site

Ushiku, , Japan

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Boehringer Ingelheim Investigational Site 1

Utsunomiya, , Japan

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Boehringer Ingelheim Investigational Site 2

Utsunomiya, , Japan

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Boehringer Ingelheim Investigational Site

Wakayama, , Japan

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Boehringer Ingelheim Investigational Site 1

Yachiyo, , Japan

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Boehringer Ingelheim Investigational Site 2

Yachiyo, , Japan

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Boehringer Ingelheim Investigational Site 3

Yachiyo, , Japan

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Boehringer Ingelheim Investigational Site

Yamanashi, , Japan

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Boehringer Ingelheim Investigational Site

Yanago, , Japan

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Boehringer Ingelheim Investigational Site

Yoichi, , Japan

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Boehringer Ingelheim Investigational Site 1

Yokohama, , Japan

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Boehringer Ingelheim Investigational Site 2

Yokohama, , Japan

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Boehringer Ingelheim Investigational Site 3

Yokohama, , Japan

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Boehringer Ingelheim Investigational Site 4

Yokohama, , Japan

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Boehringer Ingelheim Investigational Site

Yokosuka, , Japan

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Boehringer Ingelheim Investigational Site

Yoshinogawa, , Japan

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Countries

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Japan

Other Identifiers

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248.635

Identifier Type: -

Identifier Source: org_study_id

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