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A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

15. februar 2012 opdateret af: Pfizer

A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

For additional information please call: 1-800-718-1021

Undersøgelsestype

Interventionel

Tilmelding

640

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
- Alabama
  - Birmingham, Alabama, Forenede Stater
    - Pfizer Investigational Site
- Arizona
  - Mesa, Arizona, Forenede Stater
    - Pfizer Investigational Site
- California
  - Alhambra, California, Forenede Stater
    - Pfizer Investigational Site
  - Inglewood, California, Forenede Stater
    - Pfizer Investigational Site
  - Los Angeles, California, Forenede Stater
    - Pfizer Investigational Site
  - Santa Ana, California, Forenede Stater
    - Pfizer Investigational Site
- Delaware
  - Wilmington, Delaware, Forenede Stater
    - Pfizer Investigational Site
- Florida
  - Fort Lauderdale, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Hollywood, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Jacksonville, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Merritt Island, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Pensacola, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Vero Beach, Florida, Forenede Stater
    - Pfizer Investigational Site
  - Winter Park, Florida, Forenede Stater
    - Pfizer Investigational Site
- Georgia
  - Atlanta, Georgia, Forenede Stater
    - Pfizer Investigational Site
  - Conyers, Georgia, Forenede Stater
    - Pfizer Investigational Site
  - Woodstock, Georgia, Forenede Stater
    - Pfizer Investigational Site
- Illinois
  - Hinsdale, Illinois, Forenede Stater
    - Pfizer Investigational Site
  - La Grange, Illinois, Forenede Stater
    - Pfizer Investigational Site
  - Park Ridge, Illinois, Forenede Stater
    - Pfizer Investigational Site
  - Springfield, Illinois, Forenede Stater
    - Pfizer Investigational Site
- Kansas
  - Kansas City, Kansas, Forenede Stater
    - Pfizer Investigational Site
- Kentucky
  - Lexington, Kentucky, Forenede Stater
    - Pfizer Investigational Site
- Maryland
  - Baltimore, Maryland, Forenede Stater
    - Pfizer Investigational Site
  - Bethesda, Maryland, Forenede Stater
    - Pfizer Investigational Site
  - Elkton, Maryland, Forenede Stater
    - Pfizer Investigational Site
- Michigan
  - Flint, Michigan, Forenede Stater
    - Pfizer Investigational Site
- Missouri
  - Springfield, Missouri, Forenede Stater
    - Pfizer Investigational Site
- New Jersey
  - Lawrenceville, New Jersey, Forenede Stater
    - Pfizer Investigational Site
- New York
  - Albany, New York, Forenede Stater
    - Pfizer Investigational Site
  - Seaford, New York, Forenede Stater
    - Pfizer Investigational Site
- North Carolina
  - Charlotte, North Carolina, Forenede Stater
    - Pfizer Investigational Site
- Ohio
  - Cincinnati, Ohio, Forenede Stater
    - Pfizer Investigational Site
  - Mansfield, Ohio, Forenede Stater
    - Pfizer Investigational Site
- Oregon
  - Hillsboro, Oregon, Forenede Stater
    - Pfizer Investigational Site
- Pennsylvania
  - Beaver, Pennsylvania, Forenede Stater
    - Pfizer Investigational Site
  - Flourtown, Pennsylvania, Forenede Stater
    - Pfizer Investigational Site
  - Philadelphia, Pennsylvania, Forenede Stater
    - Pfizer Investigational Site
  - Yardley, Pennsylvania, Forenede Stater
    - Pfizer Investigational Site
- South Carolina
  - Greenville, South Carolina, Forenede Stater
    - Pfizer Investigational Site
- Tennessee
  - Collierville, Tennessee, Forenede Stater
    - Pfizer Investigational Site
  - Kingsport, Tennessee, Forenede Stater
    - Pfizer Investigational Site
  - Knoxville, Tennessee, Forenede Stater
    - Pfizer Investigational Site
- Texas
  - North Richland Hills, Texas, Forenede Stater
    - Pfizer Investigational Site
  - Spring, Texas, Forenede Stater
    - Pfizer Investigational Site
- Utah
  - Salt Lake City, Utah, Forenede Stater
    - Pfizer Investigational Site
  - West Jordan, Utah, Forenede Stater
    - Pfizer Investigational Site
- Virginia
  - Richmond, Virginia, Forenede Stater
    - Pfizer Investigational Site
- Washington
  - Bellevue, Washington, Forenede Stater
    - Pfizer Investigational Site
  - Puyallup, Washington, Forenede Stater
    - Pfizer Investigational Site
  - Tacoma, Washington, Forenede Stater
    - 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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

Women who are pregnant or lactating, or planning to become pregnant.
Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
Subjects with significant liver or kidney disease or significant heart failure.

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: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Procentvis ændring i LDL-C og HDL-C fra baseline efter seks ugers behandling.

Sekundære resultatmål

Resultatmål
Ændringer i andre lipidparametre og andre biomarkører.

Samarbejdspartnere og efterforskere

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

Sponsor

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. januar 2006

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)