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Survey on PD Patients With Depressive Symptoms

1 augusti 2014 uppdaterad av: Boehringer Ingelheim

BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.

i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

1089

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Japan
      • Akashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Fuchu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Fuchu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Fukuoka, 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
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Funabashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Habikino, Japan
        • Boehringer Ingelheim Investigational Site
      • Hachioji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hamamatsu, 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
      • Hanamaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Hayashima, Japan
        • Boehringer Ingelheim Investigational Site
      • Higashiosaka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Higashiosaka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Jyoetsu, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Jyoetsu, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Jyoyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Kahoku, Japan
        • Boehringer Ingelheim Investigational Site
      • Kamakura, Japan
        • Boehringer Ingelheim Investigational Site
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kanoya, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kanoya, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kashihara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kashihara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kasuga, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawagchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawaguchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kitakami, Japan
        • Boehringer Ingelheim Investigational Site
      • Kiyose, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kiyose, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Koshigaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Kure, Japan
        • Boehringer Ingelheim Investigational Site
      • Kusatsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Kyoto, 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
      • 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
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Nagoya, 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
      • Nara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Nara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Okaya, Japan
        • Boehringer Ingelheim Investigational Site
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Osaka, 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
      • 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
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Saijyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sakai, 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 8
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 9
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Sekigahara, Japan
        • Boehringer Ingelheim Investigational Site
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Shimoda, Japan
        • Boehringer Ingelheim Investigational Site
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Shinngu, Japan
        • Boehringer Ingelheim Investigational Site
      • Shiroishi, Japan
        • Boehringer Ingelheim Investigational Site
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Showajima, Japan
        • Boehringer Ingelheim Investigational Site
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Susono, Japan
        • Boehringer Ingelheim Investigational Site
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Takaoka, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Takaoka, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Tokyo Chuo-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Chuo-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Daito-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Koto-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Tokyo Minato-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 Nakano-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Nerima-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 2
      • 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
      • Tokyo Shinjyuku-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 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
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 3
      • 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
      • Utsunomiya, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Utsunomiya, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Wakayama, Japan
        • Boehringer Ingelheim Investigational Site
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Yachiyo, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Yamanashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Yanago, Japan
        • Boehringer Ingelheim Investigational Site
      • Yoichi, Japan
        • Boehringer Ingelheim Investigational Site
      • Yokohama, 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
      • Yokosuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

PD patients with depressive symptoms

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
BI-Sifrol® Tablets (Pramipexole)
BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Tidsram: for 12 weeks
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical Global Impression of Improvement
Tidsram: for 12 weeks after initiation of the treatment
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
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Tidsram: Baseline and after 12 weeks (or at the time of discontinuation)
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)
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
Tidsram: Baseline and after 12 weeks (or at the time of discontinuation)
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)
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Tidsram: Baseline and after 12 weeks (or at the time of discontinuation)
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)
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
Tidsram: After 12 weeks or at the time of discontinuation
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2007

Primärt slutförande (Faktisk)

1 augusti 2009

Studieregistreringsdatum

Först inskickad

31 januari 2008

Först inskickad som uppfyllde QC-kriterierna

12 februari 2008

Första postat (Uppskatta)

13 februari 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 augusti 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2014

Senast verifierad

1 augusti 2014

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 248.635

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera