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Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

18. december 2007 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72201
      • Little Rock, Arkansas, Forenede Stater, 72211
    • California
      • Anaheim, California, Forenede Stater, 92802
      • Anaheim, California, Forenede Stater, 92804
      • Anaheim, California, Forenede Stater, 92805
      • Boynton Beach, California, Forenede Stater, 33426
      • Costa Mesa, California, Forenede Stater, 92363
      • Costa Mesa, California, Forenede Stater, 92627
      • Escondido, California, Forenede Stater, 92025
      • Garden Grove, California, Forenede Stater, 92845
      • Glendale, California, Forenede Stater, 91206
      • Huntington Beach, California, Forenede Stater, 92648
      • La Mesa, California, Forenede Stater, 91942
      • National City, California, Forenede Stater, 91950
      • Oceanside, California, Forenede Stater, 92056
      • Paramount, California, Forenede Stater, 90723
      • Rosemead, California, Forenede Stater, 91770
      • San Diego, California, Forenede Stater, 92108
      • San Diego, California, Forenede Stater, 92123
      • San Diego, California, Forenede Stater, 92126
      • Santa Ana, California, Forenede Stater, 92705
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06050
      • New London, Connecticut, Forenede Stater, 06320
    • Florida
      • Deland, Florida, Forenede Stater, 32720
      • Ft. Lauderdale, Florida, Forenede Stater, 33319
      • Jacksonville, Florida, Forenede Stater, 32256
      • North Miami, Florida, Forenede Stater, 33161
      • St. Petersburg, Florida, Forenede Stater, 33711
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
      • Augusta, Georgia, Forenede Stater, 30912
      • Marietta, Georgia, Forenede Stater, 30060
    • Idaho
      • Coevr d'Alene, Idaho, Forenede Stater, 83814
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60631
      • Hoffman Estates, Illinois, Forenede Stater, 60194
      • Joliet, Illinois, Forenede Stater, 60077
      • Naperville, Illinois, Forenede Stater, 60540
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70601
    • Maryland
      • Gaithersburg, Maryland, Forenede Stater, 20877
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01605
    • Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
      • St. Louis, Missouri, Forenede Stater, 63118
      • St. Louis, Missouri, Forenede Stater, 63128
    • Nebraska
      • North Platte, Nebraska, Forenede Stater, 69101
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
      • Clementon, New Jersey, Forenede Stater, 08021
    • New York
      • New York, New York, Forenede Stater, 10035
      • Rochester, New York, Forenede Stater, 14624
      • Staten Island, New York, Forenede Stater, 10312
    • North Carolina
      • Butner, North Carolina, Forenede Stater, 27509
      • Chapel Hill, North Carolina, Forenede Stater, 27599
      • Durham, North Carolina, Forenede Stater, 27707
      • Morehead City, North Carolina, Forenede Stater, 28557
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58102
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73139
      • Oklahoma City, Oklahoma, Forenede Stater, 73118
    • Pennsylvania
      • Norristown, Pennsylvania, Forenede Stater, 19401
      • Philadelphia, Pennsylvania, Forenede Stater, 19149
      • Pittsburgh, Pennsylvania, Forenede Stater, 15108
    • Tennessee
      • Cordova, Tennessee, Forenede Stater, 38018
      • Memphis, Tennessee, Forenede Stater, 38105
      • Murfressboro, Tennessee, Forenede Stater, 37129
      • Nashville, Tennessee, Forenede Stater, 37212
    • Texas
      • Austin, Texas, Forenede Stater, 78756
      • DeSoto, Texas, Forenede Stater, 75115
      • Irving, Texas, Forenede Stater, 75062

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Current treatment of at least 3 months with olanzapine.
  • Primary diagnosis of schizophrenia.
  • Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening and baseline.

Exclusion criteria:

  • Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini International Neuropsychiatric Interview (MINI), and considered by the investigator to be the primary psychiatric diagnosis.
  • History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
  • History of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.

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: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change from baseline on body weight at the final evaluation.

Sekundære resultatmål

Resultatmål
Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.

Samarbejdspartnere og efterforskere

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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. juli 2006

Studieafslutning (Faktiske)

1. september 2007

Datoer for studieregistrering

Først indsendt

21. september 2006

Først indsendt, der opfyldte QC-kriterier

21. september 2006

Først opslået (Skøn)

25. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. december 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2007

Sidst verificeret

1. december 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3168A1-311

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 bifeprunox, olanzapine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner