Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.
The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ
- 1160.46.01073 Boehringer Ingelheim Investigational Site
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Florida
-
Clearwater、Florida、アメリカ
- 1160.46.01044 Boehringer Ingelheim Investigational Site
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Illinois
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Normal、Illinois、アメリカ
- 1160.46.01068 Boehringer Ingelheim Investigational Site
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Louisiana
-
Shreveport、Louisiana、アメリカ
- 1160.46.01071 Boehringer Ingelheim Investigational Site
-
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New York
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Stony Brook、New York、アメリカ
- 1160.46.01060 Boehringer Ingelheim Investigational Site
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Ohio
-
Columbus、Ohio、アメリカ
- 1160.46.01061 Boehringer Ingelheim Investigational Site
-
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Oregon
-
Bend、Oregon、アメリカ
- 1160.46.01059 Boehringer Ingelheim Investigational Site
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Corvallis、Oregon、アメリカ
- 1160.46.01063 Boehringer Ingelheim Investigational Site
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South Carolina
-
Summerville、South Carolina、アメリカ
- 1160.46.01055 Boehringer Ingelheim Investigational Site
-
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Washington
-
Bellevue、Washington、アメリカ
- 1160.46.01062 Boehringer Ingelheim Investigational Site
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-
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Headington, Oxford、イギリス
- 1160.46.44005 Boehringer Ingelheim Investigational Site
-
London、イギリス
- 1160.46.44011 Boehringer Ingelheim Investigational Site
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Newcastle upon Tyne、イギリス
- 1160.46.44006 Boehringer Ingelheim Investigational Site
-
Plymouth、イギリス
- 1160.46.44013 Boehringer Ingelheim Investigational Site
-
Sheffield、イギリス
- 1160.46.44012 Boehringer Ingelheim Investigational Site
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-
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Afula、イスラエル
- 1160.46.97202 Boehringer Ingelheim Investigational Site
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Ashkelon、イスラエル
- 1160.46.97207 Boehringer Ingelheim Investigational Site
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DN Lower Galillee、イスラエル
- 1160.46.97212 Boehringer Ingelheim Investigational Site
-
Haifa、イスラエル
- 1160.46.97211 Boehringer Ingelheim Investigational Site
-
Holon、イスラエル
- 1160.46.97203 Boehringer Ingelheim Investigational Site
-
KfarSaba、イスラエル
- 1160.46.97205 Boehringer Ingelheim Investigational Site
-
Nazareth、イスラエル
- 1160.46.97209 Boehringer Ingelheim Investigational Site
-
Petah Tiqwa、イスラエル
- 1160.46.97206 Boehringer Ingelheim Investigational Site
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Tel Aviv、イスラエル
- 1160.46.97210 Boehringer Ingelheim Investigational Site
-
Tel Hashomer, Ramat Gan、イスラエル
- 1160.46.97204 Boehringer Ingelheim Investigational Site
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Zerifin、イスラエル
- 1160.46.97201 Boehringer Ingelheim Investigational Site
-
-
-
-
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Catania、イタリア
- 1160.46.39011 Boehringer Ingelheim Investigational Site
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Firenze、イタリア
- 1160.46.39015 Boehringer Ingelheim Investigational Site
-
Palermo、イタリア
- 1160.46.39012 Boehringer Ingelheim Investigational Site
-
Reggio Emilia、イタリア
- 1160.46.39007 Boehringer Ingelheim Investigational Site
-
Verona、イタリア
- 1160.46.39013 Boehringer Ingelheim Investigational Site
-
Vittorio Veneto (TV)、イタリア
- 1160.46.39005 Boehringer Ingelheim Investigational Site
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-
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-
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Bangalore、インド
- 1160.46.91006 Boehringer Ingelheim Investigational Site
-
Bangalore、インド
- 1160.46.91010 Boehringer Ingelheim Investigational Site
-
Chennai、インド
- 1160.46.91002 Boehringer Ingelheim Investigational Site
-
Chennai、インド
- 1160.46.91007 Boehringer Ingelheim Investigational Site
-
Kolkata、インド
- 1160.46.91012 Boehringer Ingelheim Investigational Site
-
Ludhiana、インド
- 1160.46.91009 Boehringer Ingelheim Investigational Site
-
Nagpur、インド
- 1160.46.91008 Boehringer Ingelheim Investigational Site
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New Delhi、インド
- 1160.46.91005 Boehringer Ingelheim Investigational Site
-
New Delhi、インド
- 1160.46.91014 Boehringer Ingelheim Investigational Site
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Pune、インド
- 1160.46.91001 Boehringer Ingelheim Investigational Site
-
Pune、インド
- 1160.46.91004 Boehringer Ingelheim Investigational Site
-
Tamil Nadu、インド
- 1160.46.91011 Boehringer Ingelheim Investigational Site
-
Vadodara、インド
- 1160.46.91013 Boehringer Ingelheim Investigational Site
-
Vadodra、インド
- 1160.46.91003 Boehringer Ingelheim Investigational Site
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-
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Vinnitsa、ウクライナ
- 1160.46.38005 Boehringer Ingelheim Investigational Site
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-
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Alkmaar、オランダ
- 1160.46.31017 Boehringer Ingelheim Investigational Site
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Amersfoort、オランダ
- 1160.46.31001 Boehringer Ingelheim Investigational Site
-
Den Bosch、オランダ
- 1160.46.31010 Boehringer Ingelheim Investigational Site
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Eindhoven、オランダ
- 1160.46.31013 Boehringer Ingelheim Investigational Site
-
Heerlen、オランダ
- 1160.46.31014 Boehringer Ingelheim Investigational Site
-
Nieuwegein、オランダ
- 1160.46.31002 Boehringer Ingelheim Investigational Site
-
Rotterdam、オランダ
- 1160.46.31004 Boehringer Ingelheim Investigational Site
-
Zwolle、オランダ
- 1160.46.31015 Boehringer Ingelheim Investigational Site
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-
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New South Wales
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Concord、New South Wales、オーストラリア
- 1160.46.61007 Boehringer Ingelheim Investigational Site
-
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Victoria
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Box Hill、Victoria、オーストラリア
- 1160.46.61003 Boehringer Ingelheim Investigational Site
-
Clayton、Victoria、オーストラリア
- 1160.46.61001 Boehringer Ingelheim Investigational Site
-
Windsor、Victoria、オーストラリア
- 1160.46.61006 Boehringer Ingelheim Investigational Site
-
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Western Australia
-
Perth、Western Australia、オーストラリア
- 1160.46.61005 Boehringer Ingelheim Investigational Site
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-
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Quebec、カナダ
- 1160.46.02020 Boehringer Ingelheim Investigational Site
-
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Alberta
-
Edmonton、Alberta、カナダ
- 1160.46.02006 Boehringer Ingelheim Investigational Site
-
Edmonton、Alberta、カナダ
- 1160.46.02013 Boehringer Ingelheim Investigational Site
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British Columbia
-
Victoria、British Columbia、カナダ
- 1160.46.02021 Boehringer Ingelheim Investigational Site
-
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New Brunswick
-
Saint John、New Brunswick、カナダ
- 1160.46.02004 Boehringer Ingelheim Investigational Site
-
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Nova Scotia
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Halifax、Nova Scotia、カナダ
- 1160.46.02001 Boehringer Ingelheim Investigational Site
-
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Ontario
-
Hamilton、Ontario、カナダ
- 1160.46.02002 Boehringer Ingelheim Investigational Site
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Hamilton、Ontario、カナダ
- 1160.46.02005 Boehringer Ingelheim Investigational Site
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Hamilton、Ontario、カナダ
- 1160.46.02010 Boehringer Ingelheim Investigational Site
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Ottawa、Ontario、カナダ
- 1160.46.02015 Boehringer Ingelheim Investigational Site
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Toronto、Ontario、カナダ
- 1160.46.02019 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal、Quebec、カナダ
- 1160.46.02008 Boehringer Ingelheim Investigational Site
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Montreal、Quebec、カナダ
- 1160.46.02009 Boehringer Ingelheim Investigational Site
-
Montreal、Quebec、カナダ
- 1160.46.02014 Boehringer Ingelheim Investigational Site
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Montreal、Quebec、カナダ
- 1160.46.02017 Boehringer Ingelheim Investigational Site
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Singapore、シンガポール
- 1160.46.65001 Boehringer Ingelheim Investigational Site
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Singapore、シンガポール
- 1160.46.65002 Boehringer Ingelheim Investigational Site
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Singapore、シンガポール
- 1160.46.65003 Boehringer Ingelheim Investigational Site
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Göteborg、スウェーデン
- 1160.46.46002 Boehringer Ingelheim Investigational Site
-
Kristianstad、スウェーデン
- 1160.46.46010 Boehringer Ingelheim Investigational Site
-
Stockholm、スウェーデン
- 1160.46.46001 Boehringer Ingelheim Investigational Site
-
Stockholm、スウェーデン
- 1160.46.46008 Boehringer Ingelheim Investigational Site
-
Uppsala、スウェーデン
- 1160.46.46003 Boehringer Ingelheim Investigational Site
-
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Barcelona、スペイン
- 1160.46.34002 Boehringer Ingelheim Investigational Site
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Cartagena. Murcia、スペイン
- 1160.46.34007 Boehringer Ingelheim Investigational Site
-
Madrid、スペイン
- 1160.46.34009 Boehringer Ingelheim Investigational Site
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Palma de Mallorca、スペイン
- 1160.46.34015 Boehringer Ingelheim Investigational Site
-
Sabadell - barcelona、スペイン
- 1160.46.34014 Boehringer Ingelheim Investigational Site
-
Valencia、スペイン
- 1160.46.34011 Boehringer Ingelheim Investigational Site
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-
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Banska Bystrica、スロバキア
- 1160.46.42107 Boehringer Ingelheim Investigational Site
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Lucenec、スロバキア
- 1160.46.42106 Boehringer Ingelheim Investigational Site
-
Nitra、スロバキア
- 1160.46.42102 Boehringer Ingelheim Investigational Site
-
Nove Zamky、スロバキア
- 1160.46.42103 Boehringer Ingelheim Investigational Site
-
-
-
-
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Bangkok、タイ
- 1160.46.66007 Boehringer Ingelheim Investigational Site
-
Bangkok、タイ
- 1160.46.66010 Boehringer Ingelheim Investigational Site
-
Khon Kaen、タイ
- 1160.46.66001 Boehringer Ingelheim Investigational Site
-
Muang Nakhonratchasima、タイ
- 1160.46.66004 Boehringer Ingelheim Investigational Site
-
Nakhonratchasima、タイ
- 1160.46.66005 Boehringer Ingelheim Investigational Site
-
Nokorn Nayok、タイ
- 1160.46.66006 Boehringer Ingelheim Investigational Site
-
Phayathai、タイ
- 1160.46.66008 Boehringer Ingelheim Investigational Site
-
-
-
-
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Brno、チェコ共和国
- 1160.46.42001 Boehringer Ingelheim Investigational Site
-
Hradec Kralove、チェコ共和国
- 1160.46.42002 Boehringer Ingelheim Investigational Site
-
Liberec、チェコ共和国
- 1160.46.42012 Boehringer Ingelheim Investigational Site
-
Litomerice、チェコ共和国
- 1160.46.42018 Boehringer Ingelheim Investigational Site
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Novy Jicin、チェコ共和国
- 1160.46.42015 Boehringer Ingelheim Investigational Site
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Ostrava-Vitkovice、チェコ共和国
- 1160.46.42005 Boehringer Ingelheim Investigational Site
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Prague 4、チェコ共和国
- 1160.46.42017 Boehringer Ingelheim Investigational Site
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Tabor、チェコ共和国
- 1160.46.42014 Boehringer Ingelheim Investigational Site
-
Teplice、チェコ共和国
- 1160.46.42016 Boehringer Ingelheim Investigational Site
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Usti nad Labem、チェコ共和国
- 1160.46.42010 Boehringer Ingelheim Investigational Site
-
Zlin、チェコ共和国
- 1160.46.42007 Boehringer Ingelheim Investigational Site
-
-
-
-
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Aarhus C、デンマーク
- 1160.46.45001 Boehringer Ingelheim Investigational Site
-
Esbjerg、デンマーク
- 1160.46.45008 Boehringer Ingelheim Investigational Site
-
Holbæk、デンマーク
- 1160.46.45009 Boehringer Ingelheim Investigational Site
-
København NV、デンマーク
- 1160.46.45004 Boehringer Ingelheim Investigational Site
-
-
-
-
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Christchurch、ニュージーランド
- 1160.46.64004 Boehringer Ingelheim Investigational Site
-
Grafton Auckland、ニュージーランド
- 1160.46.64003 Boehringer Ingelheim Investigational Site
-
Otahuhu Auckland、ニュージーランド
- 1160.46.64002 Boehringer Ingelheim Investigational Site
-
Takapuna Auckland、ニュージーランド
- 1160.46.64001 Boehringer Ingelheim Investigational Site
-
-
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-
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Oslo、ノルウェー
- 1160.46.47001 Boehringer Ingelheim Investigational Site
-
Trondheim、ノルウェー
- 1160.46.47005 Boehringer Ingelheim Investigational Site
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-
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-
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Debrecen、ハンガリー
- 1160.46.36002 Boehringer Ingelheim Investigational Site
-
Szekesfehervar、ハンガリー
- 1160.46.36010 Boehringer Ingelheim Investigational Site
-
Szombathely、ハンガリー
- 1160.46.36011 Boehringer Ingelheim Investigational Site
-
-
-
-
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Manila、フィリピン
- 1160.46.63001 Boehringer Ingelheim Investigational Site
-
Muntinlupa、フィリピン
- 1160.46.63005 Boehringer Ingelheim Investigational Site
-
Quezon City、フィリピン
- 1160.46.63003 Boehringer Ingelheim Investigational Site
-
Quezon City、フィリピン
- 1160.46.63004 Boehringer Ingelheim Investigational Site
-
-
-
-
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Brest Cedex、フランス
- 1160.46.3301A Boehringer Ingelheim Investigational Site
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Brest Cedex、フランス
- 1160.46.3301B Boehringer Ingelheim Investigational Site
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La Roche-Sur-Yon cedex 09、フランス
- 1160.46.3315A Boehringer Ingelheim Investigational Site
-
La Roche-Sur-Yon cedex 09、フランス
- 1160.46.3315B Boehringer Ingelheim Investigational Site
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Nantes、フランス
- 1160.46.3313A Boehringer Ingelheim Investigational Site
-
Pessac、フランス
- 1160.46.3316A Boehringer Ingelheim Investigational Site
-
Pessac、フランス
- 1160.46.3316B Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303C Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303D Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303E Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303F Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303G Boehringer Ingelheim Investigational Site
-
St Etienne Cedex 2、フランス
- 1160.46.3303H Boehringer Ingelheim Investigational Site
-
St Priest En Jarez Cedex、フランス
- 1160.46.3303A Boehringer Ingelheim Investigational Site
-
St Priest En Jarez Cedex、フランス
- 1160.46.3303B Boehringer Ingelheim Investigational Site
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-
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Brasília、ブラジル
- 1160.46.55010 Boehringer Ingelheim Investigational Site
-
Campinas、ブラジル
- 1160.46.55007 Boehringer Ingelheim Investigational Site
-
Curitiba、ブラジル
- 1160.46.55014 Boehringer Ingelheim Investigational Site
-
Curitiba、ブラジル
- 1160.46.55017 Boehringer Ingelheim Investigational Site
-
Porto Alegre、ブラジル
- 1160.46.55019 Boehringer Ingelheim Investigational Site
-
Recife、ブラジル
- 1160.46.55021 Boehringer Ingelheim Investigational Site
-
Rio de Janeiro - RJ、ブラジル
- 1160.46.55016 Boehringer Ingelheim Investigational Site
-
São Bernardo do Campo、ブラジル
- 1160.46.55018 Boehringer Ingelheim Investigational Site
-
São Paulo、ブラジル
- 1160.46.55020 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Sofia、ブルガリア
- 1160.46.35901 Boehringer Ingelheim Investigational Site
-
Sofia、ブルガリア
- 1160.46.35903 Boehringer Ingelheim Investigational Site
-
Sofia、ブルガリア
- 1160.46.35906 Boehringer Ingelheim Investigational Site
-
Varna、ブルガリア
- 1160.46.35905 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Kielce、ポーランド
- 1160.46.48004 Boehringer Ingelheim Investigational Site
-
Krakow、ポーランド
- 1160.46.48001 Boehringer Ingelheim Investigational Site
-
Krakow、ポーランド
- 1160.46.48005 Boehringer Ingelheim Investigational Site
-
Poznan、ポーランド
- 1160.46.48003 Boehringer Ingelheim Investigational Site
-
Warsaw、ポーランド
- 1160.46.48006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Kelantan Kota Bahru、マレーシア
- 1160.46.60001 Boehringer Ingelheim Investigational Site
-
Melaka、マレーシア
- 1160.46.60003 Boehringer Ingelheim Investigational Site
-
Pahang、マレーシア
- 1160.46.60004 Boehringer Ingelheim Investigational Site
-
Selangor、マレーシア
- 1160.46.60002 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Chelyabinsk、ロシア連邦
- 1160.46.07021 Boehringer Ingelheim Investigational Site
-
Ekaterinburg、ロシア連邦
- 1160.46.07007 Boehringer Ingelheim Investigational Site
-
Krasnodar、ロシア連邦
- 1160.46.07016 Boehringer Ingelheim Investigational Site
-
Kursk、ロシア連邦
- 1160.46.07004 Boehringer Ingelheim Investigational Site
-
Rostov-na-Donu、ロシア連邦
- 1160.46.07009 Boehringer Ingelheim Investigational Site
-
Rostov-na-Donu、ロシア連邦
- 1160.46.07024 Boehringer Ingelheim Investigational Site
-
Ufa、ロシア連邦
- 1160.46.07014 Boehringer Ingelheim Investigational Site
-
Yaroslavl、ロシア連邦
- 1160.46.07005 Boehringer Ingelheim Investigational Site
-
Yaroslavl、ロシア連邦
- 1160.46.07006 Boehringer Ingelheim Investigational Site
-
-
-
-
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Ankara、七面鳥
- 1160.46.90003 Boehringer Ingelheim Investigational Site
-
Ankara、七面鳥
- 1160.46.90004 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90001 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90002 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90007 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90008 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90009 Boehringer Ingelheim Investigational Site
-
Istanbul、七面鳥
- 1160.46.90010 Boehringer Ingelheim Investigational Site
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-
-
-
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Beijing、中国
- 1160.46.86001 Boehringer Ingelheim Investigational Site
-
Beijing、中国
- 1160.46.86002 Boehringer Ingelheim Investigational Site
-
Beijing、中国
- 1160.46.86019 Boehringer Ingelheim Investigational Site
-
Guangzhou、中国
- 1160.46.86014 Boehringer Ingelheim Investigational Site
-
Guangzhou、中国
- 1160.46.86015 Boehringer Ingelheim Investigational Site
-
Hangzhou、中国
- 1160.46.86016 Boehringer Ingelheim Investigational Site
-
Shanghai、中国
- 1160.46.86003 Boehringer Ingelheim Investigational Site
-
Shanghai、中国
- 1160.46.86004 Boehringer Ingelheim Investigational Site
-
Shanghai、中国
- 1160.46.86005 Boehringer Ingelheim Investigational Site
-
Shanghai、中国
- 1160.46.86011 Boehringer Ingelheim Investigational Site
-
Shenyang、中国
- 1160.46.86007 Boehringer Ingelheim Investigational Site
-
Shijiazhuang、中国
- 1160.46.86017 Boehringer Ingelheim Investigational Site
-
Shijiazhuang、中国
- 1160.46.86018 Boehringer Ingelheim Investigational Site
-
Taiyuan、中国
- 1160.46.86021 Boehringer Ingelheim Investigational Site
-
Tianjin、中国
- 1160.46.86006 Boehringer Ingelheim Investigational Site
-
Yinchuan、中国
- 1160.46.86020 Boehringer Ingelheim Investigational Site
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-
-
-
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Bryanston、南アフリカ
- 1160.46.27001 Boehringer Ingelheim Investigational Site
-
Cape Town、南アフリカ
- 1160.46.27013 Boehringer Ingelheim Investigational Site
-
Centurion、南アフリカ
- 1160.46.27007 Boehringer Ingelheim Investigational Site
-
Kempton Park、南アフリカ
- 1160.46.27014 Boehringer Ingelheim Investigational Site
-
Krugersdorp、南アフリカ
- 1160.46.27015 Boehringer Ingelheim Investigational Site
-
Morningside、南アフリカ
- 1160.46.27002 Boehringer Ingelheim Investigational Site
-
Plumstead、南アフリカ
- 1160.46.27012 Boehringer Ingelheim Investigational Site
-
Sunninghill、南アフリカ
- 1160.46.27006 Boehringer Ingelheim Investigational Site
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-
-
-
-
ChangHua、台湾
- 1160.46.88607 Boehringer Ingelheim Investigational Site
-
Taipei、台湾
- 1160.46.88604 Boehringer Ingelheim Investigational Site
-
Taipei、台湾
- 1160.46.88606 Boehringer Ingelheim Investigational Site
-
Taipei、台湾
- 1160.46.88608 Boehringer Ingelheim Investigational Site
-
Taipei、台湾
- 1160.46.88609 Boehringer Ingelheim Investigational Site
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Busan、大韓民国
- 1160.46.82007 Boehringer Ingelheim Investigational Site
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Goyang-si、大韓民国
- 1160.46.82003 Boehringer Ingelheim Investigational Site
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Gyeonggi-do、大韓民国
- 1160.46.82008 Boehringer Ingelheim Investigational Site
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Gyeonggi-do、大韓民国
- 1160.46.82010 Boehringer Ingelheim Investigational Site
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Kyunggi-do、大韓民国
- 1160.46.82002 Boehringer Ingelheim Investigational Site
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Seoul、大韓民国
- 1160.46.82004 Boehringer Ingelheim Investigational Site
-
Seoul、大韓民国
- 1160.46.82005 Boehringer Ingelheim Investigational Site
-
Seoul、大韓民国
- 1160.46.82006 Boehringer Ingelheim Investigational Site
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Seoul、大韓民国
- 1160.46.82009 Boehringer Ingelheim Investigational Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
- Male or female, being 18 years of age or older
- Written informed consent for study participation
Exclusion criteria:
- Persistent symptoms of VTE
- PE requiring urgent intervention
- Use of vena cava filter
- Contraindications to anticoagulant therapy
- Allergy to study medications
- Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
- Severe renal impairment
- Patients considered unsuitable for inclusion
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
|
150mg bid
|
アクティブコンパレータ:Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
|
PRN (to maintain a target INR of 2.0-3.0)
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
再発性の症候性静脈血栓塞栓症(VTE)の参加者数とVTEに関連した死亡者数
時間枠:統計分析 1: ランダム化から治療後期間 (ptp) の終了まで、224 日目までの予定。 統計分析 2: ランダム化から 6 か月 (180 日目まで)
|
再発の疑いのあるすべての VTE とすべての死亡および出血事象は、独立した中央裁定委員会によって評価され、すべての分析はこの委員会によって集中的に確認された事象に基づいています。
|
統計分析 1: ランダム化から治療後期間 (ptp) の終了まで、224 日目までの予定。 統計分析 2: ランダム化から 6 か月 (180 日目まで)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Participants With Recurrent Symptomatic VTE and All Deaths
時間枠:For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
VTE or any death which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
|
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Number of Participants With Recurrent Symptomatic DVT
時間枠:For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Symptomatic DVT which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
|
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Number of Participants With Recurrent Symptomatic Non-fatal PE
時間枠:For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Symptomatic non-fatal PE which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
|
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Number of Participants Who Died Due to VTE
時間枠:From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
|
VTE - related deaths which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Hazard ratios and 95% CI were not calculated because of insufficient number of events.
|
From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
|
Number of Participants Who Died (Any Cause)
時間枠:For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Any deaths which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
|
For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
時間枠:For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
|
For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
|
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
時間枠:From first intake of study drug to last intake of study drug + 6 days washout
|
Major bleeding events (MBE) are defined as
Clinically-relevant bleeding events (CRBE) are defined as
Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above. |
From first intake of study drug to last intake of study drug + 6 days washout
|
Number of Participants With Acute Coronary Syndrome (ACS)
時間枠:From first intake of study drug to last contact date
|
Any ACS occurring during the conduct of the study (centrally adjudicated as definite).
Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group.
ACS assessments pre-specified in the protocol without adjudication.
Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee.
After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment.
ACS results presented are based on adjudication findings.
|
From first intake of study drug to last contact date
|
Laboratory Analyses
時間枠:From first intake of study drug to last intake of study drug + 6 days washout
|
Frequency of patients with possible clinically significant abnormalities.
|
From first intake of study drug to last intake of study drug + 6 days washout
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
- Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
- Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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