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An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME) (SUPREME)

9. juni 2011 opdateret af: Abbott

SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

199

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
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Huntington Park, California, Forenede Stater, 90255
      • Long Beach, California, Forenede Stater, 90822
      • Sacramento, California, Forenede Stater, 95825
      • Walnut Creek, California, Forenede Stater, 94598
    • Florida
      • Brooksville, Florida, Forenede Stater, 34613
      • Daytona Beach, Florida, Forenede Stater, 32117
      • Gainesville, Florida, Forenede Stater, 32605
      • Largo, Florida, Forenede Stater, 33770
      • Merritt Island, Florida, Forenede Stater, 32953
      • Miami, Florida, Forenede Stater, 33126
      • Pembroke Pines, Florida, Forenede Stater, 33026
    • Georgia
      • Calhoun, Georgia, Forenede Stater, 30701
      • Decatur, Georgia, Forenede Stater, 30034
      • Dunwoody, Georgia, Forenede Stater, 30338
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
    • Kansas
      • Arkansas City, Kansas, Forenede Stater, 67005
      • Newton, Kansas, Forenede Stater, 67114
      • Shawnee Mission, Kansas, Forenede Stater, 66216
      • Topeka, Kansas, Forenede Stater, 55508
      • Wichita, Kansas, Forenede Stater, 67203
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
    • Montana
      • Missoula, Montana, Forenede Stater, 59808
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
      • High Point, North Carolina, Forenede Stater, 27262
    • Ohio
      • Canfield, Ohio, Forenede Stater, 44406
      • Cincinnati, Ohio, Forenede Stater, 45242
      • Dayton, Ohio, Forenede Stater, 45458
    • Oregon
      • Protland, Oregon, Forenede Stater, 97239
    • Pennsylvania
      • Chicora, Pennsylvania, Forenede Stater, 16025
      • Duncansville, Pennsylvania, Forenede Stater, 16635
      • Harleysville, Pennsylvania, Forenede Stater, 19438
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
    • Texas
      • Austin, Texas, Forenede Stater, 78752
      • Carrollton, Texas, Forenede Stater, 75006
      • Dallas, Texas, Forenede Stater, 75251
      • Houston, Texas, Forenede Stater, 77074
      • San Antonio, Texas, Forenede Stater, 78224
    • Utah
      • Magna, Utah, Forenede Stater, 84044
      • Salt Lake City, Utah, Forenede Stater, 84107
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23249
    • Washington
      • Gig Harbor, Washington, Forenede Stater, 98335
    • Wisconsin
      • Menomonee Falls, Wisconsin, Forenede Stater, 53051
      • Milwaukee, Wisconsin, Forenede Stater, 53209

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects must meet all of the following laboratory criteria:

    • HDL-C <40 mg/dL for men and <50 mg/dL for women.
    • LDL-C ≥130 mg/dL but <250 mg/dL.
    • TG <350 mg/dL.
    • Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).
    • Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN.
  • Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).

Exclusion Criteria:

  • Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

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)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: Niacin ER/Simvastatin Tablets
Up to 2000 mg/40 mg at bedtime
Andre navne:
  • ABT-919/483
  • Niacin ER/Simvastatin
  • Simcor
Eksperimentel: 2
Medicin: atorvastatin
40 mg at bedtime

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
From baseline to Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change in HDL-C From Baseline to Week 8
Tidsramme: From baseline to Week 8
(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8
Tidsramme: From baseline to Week 8
(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
From baseline to Week 12
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
From baseline to Week 12
Percent Change in Triglycerides From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
From baseline to Week 12
Percent Change in LDL-C:HDL-C Ratio
Tidsramme: From baseline to Week 12
(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio
From baseline to Week 12
Percent Change in Total Cholesterol From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
From baseline to Week 12
Percent Change in Total Cholesterol:HDL-C Ratio
Tidsramme: From baseline to Week 12
(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio
From baseline to Week 12
Percent Change in Lipoprotein A From Baseline to Week 12
Tidsramme: From baseline to Week 12
(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A
From baseline to Week 12
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
Tidsramme: 12 weeks
12 weeks
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
Tidsramme: 12 weeks
For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.
12 weeks
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
Tidsramme: 12 weeks
12 weeks
Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
Tidsramme: 12 weeks
NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott

Efterforskere

  • Studieleder: Roopal Thakkar, MD, Abbott

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. april 2007

Primær færdiggørelse (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

23. april 2007

Først indsendt, der opfyldte QC-kriterier

23. april 2007

Først opslået (Skøn)

24. april 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juni 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2011

Sidst verificeret

1. juni 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 019-05-06-CR
  • M10-013

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 .

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