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

3. juni 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

512

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dabigatran etexilate 110 mg
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Legemiddel: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Legemiddel: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Eksperimentell: Dabigatran etexilate 150 mg
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Legemiddel: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, once a day, oral administration
Legemiddel: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, once a day, oral administration
Eksperimentell: Dabigatran etexilate 220 mg
Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration
Legemiddel: Dabigatran Etexilate
Dabigatran etexilate 220 mg capsule, once a day, oral administration
Placebo komparator: Placebo
matching placebo capsule, once a day, oral administration
Legemiddel: placebo
matching placebo capsule, once a day, oral administration

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Laboratorieanalyser
Tidsramme: Første administrasjon til slutten av studiet
Hyppighet av pasienter med mulige klinisk signifikante abnormiteter.
Første administrasjon til slutten av 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2005

Primær fullføring (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først innsendt

28. oktober 2005

Først innsendt som oppfylte QC-kriteriene

28. oktober 2005

Først lagt ut (Anslag)

30. oktober 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1160.50

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Dabigatran etexilate

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Russia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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