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A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

5. november 2012 opdateret af: Pfizer

A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2536

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E 7C5
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4R 2G4
        • Pfizer Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1E 1J7
        • Pfizer Investigational Site
    • Quebec
      • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2W 1R7
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Fairhope, Alabama, Forenede Stater, 36532
        • Pfizer Investigational Site
      • Huntsville, Alabama, Forenede Stater, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36608
        • Pfizer Investigational Site
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Pfizer Investigational Site
      • Oakland, California, Forenede Stater, 94609-3223
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92128
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92130
        • Pfizer Investigational Site
      • Santa Ana, California, Forenede Stater, 92705
        • Pfizer Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Pfizer Investigational Site
    • Colorado
      • Longmont, Colorado, Forenede Stater, 80501
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, Forenede Stater, 32809
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • Pfizer Investigational Site
      • Gurnee, Illinois, Forenede Stater, 60031
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Pfizer Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40213
        • Pfizer Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40223
        • Pfizer Investigational Site
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pfizer Investigational Site
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Pfizer Investigational Site
    • Maine
      • Scarborough, Maine, Forenede Stater, 04074
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Pfizer Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Pfizer Investigational Site
      • Milford, Massachusetts, Forenede Stater, 01757
        • Pfizer Investigational Site
      • North Dartmouth, Massachusetts, Forenede Stater, 02747
        • Pfizer Investigational Site
    • Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, Forenede Stater, 55318
        • Pfizer Investigational Site
      • Edina, Minnesota, Forenede Stater, 55435
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Pfizer Investigational Site
      • Waconia, Minnesota, Forenede Stater, 55387
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
        • Pfizer Investigational Site
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater, 08690
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Pfizer Investigational Site
    • New York
      • Endwell, New York, Forenede Stater, 13760
        • Pfizer Investigational Site
      • Kingston, New York, Forenede Stater, 12401
        • Pfizer Investigational Site
      • Manlius, New York, Forenede Stater, 13104
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater, 10021-7903
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14609
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, Forenede Stater, 27215
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28211
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28277
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, Forenede Stater, 44311
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, Forenede Stater, 02864
        • Pfizer Investigational Site
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, Forenede Stater, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Pfizer Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Pfizer Investigational Site
      • Beaumont, Texas, Forenede Stater, 77701
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75390-8858
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76137
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76135
        • Pfizer Investigational Site
      • Lake Jackson, Texas, Forenede Stater, 77566
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22911
        • Pfizer Investigational Site
      • Norfolk, Virginia, Forenede Stater, 23502
        • Pfizer Investigational Site
      • Richmond, Virginia, Forenede Stater, 23294
        • Pfizer Investigational Site
    • Washington
      • Olympia, Washington, Forenede Stater, 98502
        • Pfizer Investigational Site
      • Renton, Washington, Forenede Stater, 98057
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506-9136
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Pfizer Investigational Site
      • Oregon, Wisconsin, Forenede Stater, 53575
        • Pfizer 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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

Exclusion Criteria:

  • Pregnancy
  • Diabetes
  • Adults with serious or unstable current or past medical conditions

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
Eksperimentel: CP-945.598 Behandling B
Medicin: CP-945,598 Treatment B
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Eksperimentel: CP-945.598 Behandling A
Medicin: CP-945,598 Treatment A
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of subjects with 5% weight loss
Tidsramme: 1 year
1 year
Change in body weight
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Blood pressure, blood lipids and glucose, waist circumference, quality of life
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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 2006

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

11. september 2006

Først indsendt, der opfyldte QC-kriterier

11. september 2006

Først opslået (Skøn)

13. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • A5351025

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 CP-945,598 Treatment A

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Türkiye

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner