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Survey on PD Patients With Depressive Symptoms

1. August 2014 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

1089

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

PD patients with depressive symptoms

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical Global Impression of Improvement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2007

Primärer Abschluss (Tatsächlich)

1. August 2009

Studienanmeldedaten

Zuerst eingereicht

31. Januar 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Februar 2008

Zuerst gepostet (Schätzen)

13. Februar 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

6. August 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. August 2014

Zuletzt verifiziert

1. August 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 248.635

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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