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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614575
Other study ID # 248.635
Secondary ID
Status Completed
Phase N/A
First received January 31, 2008
Last updated August 1, 2014
Start date January 2007

Study information

Verified date August 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1089
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Boehringer Ingelheim Investigational Site Akashi
Japan Boehringer Ingelheim Investigational Site 1 Akita
Japan Boehringer Ingelheim Investigational Site 2 Akita
Japan Boehringer Ingelheim Investigational Site Asahikawa
Japan Boehringer Ingelheim Investigational Site Ashikaga
Japan Boehringer Ingelheim Investigational Site Awaji
Japan Boehringer Ingelheim Investigational Site Chitose
Japan Boehringer Ingelheim Investigational Site Chuo
Japan Boehringer Ingelheim Investigational Site 1 Fuchu
Japan Boehringer Ingelheim Investigational Site 2 Fuchu
Japan Boehringer Ingelheim Investigational Site Fuefuki
Japan Boehringer Ingelheim Investigational Site Fuehuki
Japan Boehringer Ingelheim Investigational Site Fujioka
Japan Boehringer Ingelheim Investigational Site Fujisaki
Japan Boehringer Ingelheim Investigational Site Fujisawa
Japan Boehringer Ingelheim Investigational Site Fukaya
Japan Boehringer Ingelheim Investigational Site 1 Fukuoka
Japan Boehringer Ingelheim Investigational Site 2 Fukuoka
Japan Boehringer Ingelheim Investigational Site 3 Fukuoka
Japan Boehringer Ingelheim Investigational Site 4 Fukuoka
Japan Boehringer Ingelheim Investigational Site 5 Fukuoka
Japan Boehringer Ingelheim Investigational Site 1 Fukushima
Japan Boehringer Ingelheim Investigational Site 2 Fukushima
Japan Boehringer Ingelheim Investigational Site Funabashi
Japan Boehringer Ingelheim Investigational Site 1 Gifu
Japan Boehringer Ingelheim Investigational Site 2 Gifu
Japan Boehringer Ingelheim Investigational Site Habikino
Japan Boehringer Ingelheim Investigational Site Hachioji
Japan Boehringer Ingelheim Investigational Site 1 Hamamatsu
Japan Boehringer Ingelheim Investigational Site 2 Hamamatsu
Japan Boehringer Ingelheim Investigational Site 3 Hamamatsu
Japan Boehringer Ingelheim Investigational Site 4 Hamamatsu
Japan Boehringer Ingelheim Investigational Site 5 Hamamatsu
Japan Boehringer Ingelheim Investigational Site Hanamaki
Japan Boehringer Ingelheim Investigational Site Hayashima
Japan Boehringer Ingelheim Investigational Site 1 Higashiosaka
Japan Boehringer Ingelheim Investigational Site 2 Higashiosaka
Japan Boehringer Ingelheim Investigational Site Himeji
Japan Boehringer Ingelheim Investigational Site Hirakata
Japan Boehringer Ingelheim Investigational Site Hirishima
Japan Boehringer Ingelheim Investigational Site Hirosaki
Japan Boehringer Ingelheim Investigational Site Ibaragi
Japan Boehringer Ingelheim Investigational Site Iizuka
Japan Boehringer Ingelheim Investigational Site Inag
Japan Boehringer Ingelheim Investigational Site Irima
Japan Boehringer Ingelheim Investigational Site Isahaya
Japan Boehringer Ingelheim Investigational Site Iwaki
Japan Boehringer Ingelheim Investigational Site Iwamizawa
Japan Boehringer Ingelheim Investigational Site Iwata
Japan Boehringer Ingelheim Investigational Site 1 Jyoetsu
Japan Boehringer Ingelheim Investigational Site 2 Jyoetsu
Japan Boehringer Ingelheim Investigational Site Jyoyo
Japan Boehringer Ingelheim Investigational Site 1 Kagoshima
Japan Boehringer Ingelheim Investigational Site 2 Kagoshima
Japan Boehringer Ingelheim Investigational Site 3 Kagoshima
Japan Boehringer Ingelheim Investigational Site Kahoku
Japan Boehringer Ingelheim Investigational Site Kamakura
Japan Boehringer Ingelheim Investigational Site 1 Kanazawa
Japan Boehringer Ingelheim Investigational Site 2 Kanazawa
Japan Boehringer Ingelheim Investigational Site 1 Kanoya
Japan Boehringer Ingelheim Investigational Site 2 Kanoya
Japan Boehringer Ingelheim Investigational Site 1 Kashihara
Japan Boehringer Ingelheim Investigational Site 2 Kashihara
Japan Boehringer Ingelheim Investigational Site Kasuga
Japan Boehringer Ingelheim Investigational Site Kawagchi
Japan Boehringer Ingelheim Investigational Site Kawaguchi
Japan Boehringer Ingelheim Investigational Site 1 Kawasaki
Japan Boehringer Ingelheim Investigational Site 2 Kawasaki
Japan Boehringer Ingelheim Investigational Site Kitakami
Japan Boehringer Ingelheim Investigational Site 1 Kiyose
Japan Boehringer Ingelheim Investigational Site 2 Kiyose
Japan Boehringer Ingelheim Investigational Site Kodaira
Japan Boehringer Ingelheim Investigational Site Kofu
Japan Boehringer Ingelheim Investigational Site Koga
Japan Boehringer Ingelheim Investigational Site Komae
Japan Boehringer Ingelheim Investigational Site Komatsu
Japan Boehringer Ingelheim Investigational Site Komatsushima
Japan Boehringer Ingelheim Investigational Site 1 Koriyama
Japan Boehringer Ingelheim Investigational Site 2 Koriyama
Japan Boehringer Ingelheim Investigational Site Koshigaya
Japan Boehringer Ingelheim Investigational Site 1 Kumamoto
Japan Boehringer Ingelheim Investigational Site 2 Kumamoto
Japan Boehringer Ingelheim Investigational Site 3 Kumamoto
Japan Boehringer Ingelheim Investigational Site Kure
Japan Boehringer Ingelheim Investigational Site Kusatsu
Japan Boehringer Ingelheim Investigational Site 1 Kyoto
Japan Boehringer Ingelheim Investigational Site 2 Kyoto
Japan Boehringer Ingelheim Investigational Site 3 Kyoto
Japan Boehringer Ingelheim Investigational Site 4 Kyoto
Japan Boehringer Ingelheim Investigational Site Maebashi
Japan Boehringer Ingelheim Investigational Site Matsudo
Japan Boehringer Ingelheim Investigational Site Matsumoto
Japan Boehringer Ingelheim Investigational Site Mibu
Japan Boehringer Ingelheim Investigational Site Mihara
Japan Boehringer Ingelheim Investigational Site Mihoro
Japan Boehringer Ingelheim Investigational Site Miriyama
Japan Boehringer Ingelheim Investigational Site Misato
Japan Boehringer Ingelheim Investigational Site Miyako
Japan Boehringer Ingelheim Investigational Site 1 Miyazaki
Japan Boehringer Ingelheim Investigational Site 2 Miyazaki
Japan Boehringer Ingelheim Investigational Site Moriguchi
Japan Boehringer Ingelheim Investigational Site 1 Morioka
Japan Boehringer Ingelheim Investigational Site 2 Morioka
Japan Boehringer Ingelheim Investigational Site Moriya
Japan Boehringer Ingelheim Investigational Site Musashino
Japan Boehringer Ingelheim Investigational Site Nagano
Japan Boehringer Ingelheim Investigational Site Nagaoka
Japan Boehringer Ingelheim Investigational Site Nagaokakyo
Japan Boehringer Ingelheim Investigational Site 1 Nagoya
Japan Boehringer Ingelheim Investigational Site 2 Nagoya
Japan Boehringer Ingelheim Investigational Site 3 Nagoya
Japan Boehringer Ingelheim Investigational Site 4 Nagoya
Japan Boehringer Ingelheim Investigational Site 1 Nara
Japan Boehringer Ingelheim Investigational Site 2 Nara
Japan Boehringer Ingelheim Investigational Site Narashino
Japan Boehringer Ingelheim Investigational Site Narita
Japan Boehringer Ingelheim Investigational Site Naruto
Japan Boehringer Ingelheim Investigational Site Nasushiobara
Japan Boehringer Ingelheim Investigational Site Nichinan
Japan Boehringer Ingelheim Investigational Site Ninohe
Japan Boehringer Ingelheim Investigational Site Nishinomiya
Japan Boehringer Ingelheim Investigational Site Nishitokyo
Japan Boehringer Ingelheim Investigational Site Ogaki
Japan Boehringer Ingelheim Investigational Site Oiso
Japan Boehringer Ingelheim Investigational Site 1 Oita
Japan Boehringer Ingelheim Investigational Site 2 Oita
Japan Boehringer Ingelheim Investigational Site 3 Oita
Japan Boehringer Ingelheim Investigational Site Okaya
Japan Boehringer Ingelheim Investigational Site 1 Okayama
Japan Boehringer Ingelheim Investigational Site 2 Okayama
Japan Boehringer Ingelheim Investigational Site Okazaki
Japan Boehringer Ingelheim Investigational Site Okinawa
Japan Boehringer Ingelheim Investigational Site Omura
Japan Boehringer Ingelheim Investigational Site Omuta
Japan Boehringer Ingelheim Investigational Site Onojyo
Japan Boehringer Ingelheim Investigational Site 1 Osaka
Japan Boehringer Ingelheim Investigational Site 2 Osaka
Japan Boehringer Ingelheim Investigational Site 3 Osaka
Japan Boehringer Ingelheim Investigational Site 4 Osaka
Japan Boehringer Ingelheim Investigational Site 5 Osaka
Japan Boehringer Ingelheim Investigational Site 6 Osaka
Japan Boehringer Ingelheim Investigational Site Ota
Japan Boehringer Ingelheim Investigational Site Otake
Japan Boehringer Ingelheim Investigational Site Otsu
Japan Boehringer Ingelheim Investigational Site Ryugasaki
Japan Boehringer Ingelheim Investigational Site Saeki
Japan Boehringer Ingelheim Investigational Site Saga
Japan Boehringer Ingelheim Investigational Site 1 Sagamihara
Japan Boehringer Ingelheim Investigational Site 2 Sagamihara
Japan Boehringer Ingelheim Investigational Site 3 Sagamihara
Japan Boehringer Ingelheim Investigational Site Saijyo
Japan Boehringer Ingelheim Investigational Site Saitama
Japan Boehringer Ingelheim Investigational Site 1 Sakai
Japan Boehringer Ingelheim Investigational Site 2 Sakai
Japan Boehringer Ingelheim Investigational Site 1 Sapporo
Japan Boehringer Ingelheim Investigational Site 2 Sapporo
Japan Boehringer Ingelheim Investigational Site 3 Sapporo
Japan Boehringer Ingelheim Investigational Site 4 Sapporo
Japan Boehringer Ingelheim Investigational Site 5 Sapporo
Japan Boehringer Ingelheim Investigational Site 6 Sapporo
Japan Boehringer Ingelheim Investigational Site 7 Sapporo
Japan Boehringer Ingelheim Investigational Site 8 Sapporo
Japan Boehringer Ingelheim Investigational Site 9 Sapporo
Japan Boehringer Ingelheim Investigational Site Sekigahara
Japan Boehringer Ingelheim Investigational Site 1 Sendai
Japan Boehringer Ingelheim Investigational Site 2 Sendai
Japan Boehringer Ingelheim Investigational Site Shimoda
Japan Boehringer Ingelheim Investigational Site 1 Shimotsuke
Japan Boehringer Ingelheim Investigational Site 2 Shimotsuke
Japan Boehringer Ingelheim Investigational Site Shinngu
Japan Boehringer Ingelheim Investigational Site Shiroishi
Japan Boehringer Ingelheim Investigational Site 1 Shizuoka
Japan Boehringer Ingelheim Investigational Site 2 Shizuoka
Japan Boehringer Ingelheim Investigational Site Showajima
Japan Boehringer Ingelheim Investigational Site 1 Suita
Japan Boehringer Ingelheim Investigational Site 2 Suita
Japan Boehringer Ingelheim Investigational Site Susono
Japan Boehringer Ingelheim Investigational Site Suzuka
Japan Boehringer Ingelheim Investigational Site 1 Takaoka
Japan Boehringer Ingelheim Investigational Site 2 Takaoka
Japan Boehringer Ingelheim Investigational Site Takatsuki
Japan Boehringer Ingelheim Investigational Site Tarimizu
Japan Boehringer Ingelheim Investigational Site Togitsu
Japan Boehringer Ingelheim Investigational Site Tokoname
Japan Boehringer Ingelheim Investigational Site Tokushima
Japan Boehringer Ingelheim Investigational Site Tokyo Arakawa-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Bunkyo-ku
Japan Boehringer Ingelheim Investigational Site 1 Tokyo Chuo-ku
Japan Boehringer Ingelheim Investigational Site 2 Tokyo Chuo-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Daito-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Koto-ku
Japan Boehringer Ingelheim Investigational Site 1 Tokyo Meguro-ku
Japan Boehringer Ingelheim Investigational Site 2 Tokyo Meguro-ku
Japan Boehringer Ingelheim Investigational Site 1 Tokyo Minato-ku
Japan Boehringer Ingelheim Investigational Site 2 Tokyo Minato-ku
Japan Boehringer Ingelheim Investigational Site 3 Tokyo Minato-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Nakano-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Nerima-ku
Japan Boehringer Ingelheim Investigational Site 1 Tokyo Ota-ku
Japan Boehringer Ingelheim Investigational Site 2 Tokyo Ota-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Setagaya
Japan Boehringer Ingelheim Investigational Site Tokyo Setagaya-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Shibuya-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Shinagawa-ku
Japan Boehringer Ingelheim Investigational Site 1 Tokyo Shinjyuku-ku
Japan Boehringer Ingelheim Investigational Site 2 Tokyo Shinjyuku-ku
Japan Boehringer Ingelheim Investigational Site 3 Tokyo Shinjyuku-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Sibuya-ku
Japan Boehringer Ingelheim Investigational Site Tokyo Toshima-ku
Japan Boehringer Ingelheim Investigational Site Tokyo-Edogawa-ku
Japan Boehringer Ingelheim Investigational Site Tokyo-Itabashi-ku
Japan Boehringer Ingelheim Investigational Site Toride
Japan Boehringer Ingelheim Investigational Site Tosu
Japan Boehringer Ingelheim Investigational Site 1 Toyama
Japan Boehringer Ingelheim Investigational Site 2 Toyama
Japan Boehringer Ingelheim Investigational Site 3 Toyama
Japan Boehringer Ingelheim Investigational Site Toyohashi
Japan Boehringer Ingelheim Investigational Site Toyokawa
Japan Boehringer Ingelheim Investigational Site Toyonaka
Japan Boehringer Ingelheim Investigational Site Ube
Japan Boehringer Ingelheim Investigational Site Uchinada
Japan Boehringer Ingelheim Investigational Site Ueda
Japan Boehringer Ingelheim Investigational Site Ushiku
Japan Boehringer Ingelheim Investigational Site 1 Utsunomiya
Japan Boehringer Ingelheim Investigational Site 2 Utsunomiya
Japan Boehringer Ingelheim Investigational Site Wakayama
Japan Boehringer Ingelheim Investigational Site 1 Yachiyo
Japan Boehringer Ingelheim Investigational Site 2 Yachiyo
Japan Boehringer Ingelheim Investigational Site 3 Yachiyo
Japan Boehringer Ingelheim Investigational Site Yamanashi
Japan Boehringer Ingelheim Investigational Site Yanago
Japan Boehringer Ingelheim Investigational Site Yoichi
Japan Boehringer Ingelheim Investigational Site 1 Yokohama
Japan Boehringer Ingelheim Investigational Site 2 Yokohama
Japan Boehringer Ingelheim Investigational Site 3 Yokohama
Japan Boehringer Ingelheim Investigational Site 4 Yokohama
Japan Boehringer Ingelheim Investigational Site Yokosuka
Japan Boehringer Ingelheim Investigational Site Yoshinogawa

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented. for 12 weeks No
Secondary Clinical Global Impression of Improvement Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). for 12 weeks after initiation of the treatment No
Secondary Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement. Baseline and after 12 weeks (or at the time of discontinuation) No
Secondary Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement. Baseline and after 12 weeks (or at the time of discontinuation) No
Secondary Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement. Baseline and after 12 weeks (or at the time of discontinuation) No
Secondary Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement. After 12 weeks or at the time of discontinuation No
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