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A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

3. juni 2014 opdateret af: Boehringer Ingelheim

A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

512

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Eniwa, Hokkaido, Japan
        • 1160.50.001 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 1160.50.018 Boehringer Ingelheim Investigational Site
      • Hachioji, Tokyo, Japan
        • 1160.50.008 Boehringer Ingelheim Investigational Site
      • Hirosaki, Aomori, Japan
        • 1160.50.006 Boehringer Ingelheim Investigational Site
      • Hiroshima, Hiroshima, Japan
        • 1160.50.026 Boehringer Ingelheim Investigational Site
      • Iida, Nagano, Japan
        • 1160.50.011 Boehringer Ingelheim Investigational Site
      • Izumisano, Osaka, Japan
        • 1160.50.024 Boehringer Ingelheim Investigational Site
      • Izunokuni,Shizuoka, Japan
        • 1160.50.045 Boehringer Ingelheim Investigational Site
      • Kagoshima, Kagoshima, Japan
        • 1160.50.022 Boehringer Ingelheim Investigational Site
      • Kawasaki, Kanagawa, Japan
        • 1160.50.027 Boehringer Ingelheim Investigational Site
      • Kawasaki, Kanagawa, Japan
        • 1160.50.032 Boehringer Ingelheim Investigational Site
      • Kitakyusyu, Fukuoka, Japan
        • 1160.50.041 Boehringer Ingelheim Investigational Site
      • Koshigaya,Saitama, Japan
        • 1160.50.039 Boehringer Ingelheim Investigational Site
      • Kurume ,Fukuoka, Japan
        • 1160.50.037 Boehringer Ingelheim Investigational Site
      • Kurume ,Fukuoka, Japan
        • 1160.50.038 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japan
        • 1160.50.013 Boehringer Ingelheim Investigational Site
      • Matsue, Shimane, Japan
        • 1160.50.036 Boehringer Ingelheim Investigational Site
      • Miyazaki, Miyazaki, Japan
        • 1160.50.042 Boehringer Ingelheim Investigational Site
      • Musashimurayama, Tokyo, Japan
        • 1160.50.028 Boehringer Ingelheim Investigational Site
      • Obihiro, Hokkaido, Japan
        • 1160.50.005 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama, Japan
        • 1160.50.030 Boehringer Ingelheim Investigational Site
      • Omura, Nagasaki, Japan
        • 1160.50.021 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1160.50.014 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1160.50.015 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1160.50.016 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1160.50.033 Boehringer Ingelheim Investigational Site
      • Saga, Saga, Japan
        • 1160.50.031 Boehringer Ingelheim Investigational Site
      • Sagamihara, Kanagawa, Japan
        • 1160.50.009 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1160.50.002 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1160.50.004 Boehringer Ingelheim Investigational Site
      • Sasebo, Nagasaki, Japan
        • 1160.50.020 Boehringer Ingelheim Investigational Site
      • Sasebo, Nagasaki, Japan
        • 1160.50.025 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 1160.50.034 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku,Tokyo, Japan
        • 1160.50.029 Boehringer Ingelheim Investigational Site
      • Shizuoka, Shizuoka, Japan
        • 1160.50.043 Boehringer Ingelheim Investigational Site
      • Sumida-ku, Tokyo, Japan
        • 1160.50.044 Boehringer Ingelheim Investigational Site
      • Tomigusuku, Okinawa, Japan
        • 1160.50.023 Boehringer Ingelheim Investigational Site
      • Tsukuba , Ibaraki, Japan
        • 1160.50.040 Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria Inclusion criteria

  1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
  2. Male or Female 20 years of age or order
  3. Patients weighing at least 40 kg
  4. Written informed consent prior to the start of study participation

Exclusion criteria Exclusion criteria

  1. History of bleeding diathesis
  2. Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
  3. Major surgery or trauma (e.g. hip fracture) within the last 3 months
  4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
  5. Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
  6. Condition requiring anti-coagulant therapy
  7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
  8. Patients with a history of clinically significant renal diseases or with elevated creatinine values

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dabigatran etexilate 110 mg
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Medicin: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Medicin: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Eksperimentel: Dabigatran etexilate 150 mg
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Medicin: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Medicin: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Eksperimentel: Dabigatran etexilate 220 mg
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
Medicin: Dabigatran Etexilate
Dabigatran etexilate 220 mg capsule, once a day, oral administration
Placebo komparator: Placebo
matching placebo capsule, once a day, oral administration
Medicin: placebo
matching placebo capsule, once a day, oral administration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
Tidsramme: 2 weeks study medication
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality
2 weeks study medication

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Laboratorieanalyser
Tidsramme: Første administration til afslutning af studiet
Hyppighed af patienter med mulige klinisk signifikante abnormiteter.
Første administration til afslutning af studiet
Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality
Tidsramme: 2 weeks
Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality
2 weeks
Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period
Tidsramme: 2 weeks
Number of participants who have Proximal DVT during treatment period
2 weeks
Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)
Tidsramme: 2 weeks
Number of Participants expressing DVT with symptoms
2 weeks
Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period
Tidsramme: 2 weeks
Number of participants who have Total DVT during treatment period
2 weeks
Number of Participants With Pulmonary Embolism During Treatment Period
Tidsramme: 2 weeks
Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.
2 weeks
Number of Participants Who Died During Treatment Period
Tidsramme: 2 weeks
All cause death, as adjudicated by the VTE events committee.
2 weeks
Number of Participants With Bleeding Events During Treatment Period
Tidsramme: 2 weeks

Major bleeding events were defined as

  • fatal
  • clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected
  • clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
  • symptomatic retroperitoneal, intracranial, intraocular or intraspinal
  • requiring treatment cessation
  • leading to re-operation

Clinically-relevant was defined as

  • spontaneous skin hematoma >=25 cm²
  • wound hematoma >=100 cm²
  • spontaneous nose bleed >5 min
  • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
  • spontaneous rectal bleeding (more than a spot on toilet paper)
  • gingival bleeding >5 min
  • any other bleeding event considered clinically relevant by the investigator

Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
2 weeks
Blood Transfusion
Tidsramme: Day 0
Blood transfusion for treated and operated patients on Day of surgery.
Day 0
Volume of Blood Loss
Tidsramme: Day 0
Volume of blood loss for treated and operated patients during surgery.
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Primær færdiggørelse (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

28. oktober 2005

Først indsendt, der opfyldte QC-kriterier

28. oktober 2005

Først opslået (Skøn)

30. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1160.50

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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