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Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.

20. juni 2014 opdateret af: Boehringer Ingelheim

Assessment of Electrophysiological Effects of 150 mg and 600 mg of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind Three-way Crossover Study With an Open Label Positive Control (Moxifloxacin)

To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 1

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Healthy female (at least 1/3) and male (at least 1/3) volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
  2. Age >= 18 and Age <= 65 years
  3. BMI >= 20.0 and BMI <=29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  8. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  12. Inability to refrain from smoking on trial days
  13. Alcohol abuse (more than 60 g/day)
  14. Drug abuse
  15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  16. History of any bleeding disorder or acute blood coagulation defect
  17. Hypersensitivity to moxifloxacin and/or related drugs of this class
  18. Excessive physical activities (within one week prior to administration or during the trial)
  19. Any laboratory value outside the reference range that is of clinical relevance
  20. Inability to comply with dietary regimen of study centre
  21. History of additional risk factors for Torsade des Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
  22. Any screening ECG value outside of the reference range of clinical relevance including, but not limited to heart rate of >80 bpm or <45 bpm, PR interval >220 ms, QRS interval >120 ms, QT interval >470 ms or QTcB or QTcF >450 ms

    For female subjects:

  23. Pregnancy
  24. Positive pregnancy test
  25. No adequate contraception e.g. oral contraceptives, sterilisation, intrauterine device (IUD)
  26. Inability to maintain this adequate contraception during the whole study period
  27. Lactation period

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Moxifloxacin
Eksperimentel: Dabigatran etexilat lavt
Eksperimentel: Dabigatran etexilat høj
Placebo komparator: Placebo to dabigatran etexilate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in mean time-matched QTc Interval
Tidsramme: at 1.5, 2, and 3 hours following administration
at 1.5, 2, and 3 hours following administration

Sekundære resultatmål

Resultatmål
Tidsramme
Mean of the QTcI values of all ECGs
Tidsramme: from 1 to 6 hours following administration
from 1 to 6 hours following administration
Change from baseline of the QTcI
Tidsramme: from 1 to 24 hours following administration
from 1 to 24 hours following administration

Samarbejdspartnere og efterforskere

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

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. marts 2006

Primær færdiggørelse (Faktiske)

1. maj 2006

Datoer for studieregistrering

Først indsendt

20. juni 2014

Først indsendt, der opfyldte QC-kriterier

20. juni 2014

Først opslået (Skøn)

23. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2014

Sidst verificeret

1. juni 2014

Mere information

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 .

Kliniske forsøg med Placebo

3
Abonner