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Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol

23. maj 2012 opdateret af: Takeda

A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 100 mg Versus Placebo in Subjects With Primary Hypercholesterolemia

The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will evaluate the efficacy and safety of TAK-475 (lapaquistat acetate) compared to placebo in subjects with primary hypercholesterolemia. Subjects who have signed the informed consent will undergo necessary evaluations to determine eligibility for a dietary run-in phase. Subjects who meet randomization criteria will enter treatment with one of the following randomized treatments: lapaquistat acetate or placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

361

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
      • Northport, Alabama, Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater
    • California
      • Chula Vista, California, Forenede Stater
      • Encinitas, California, Forenede Stater
      • Long Beach, California, Forenede Stater
      • Pismo Beach, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Colorado
      • Golden, Colorado, Forenede Stater
    • Florida
      • Aventura, Florida, Forenede Stater
      • Clearwater, Florida, Forenede Stater
      • Daytona Beach, Florida, Forenede Stater
      • Hollywood, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Jupiter, Florida, Forenede Stater
      • New Port Richy, Florida, Forenede Stater
      • Pembroke Pines, Florida, Forenede Stater
    • Illinois
      • Elk Grove Village, Illinois, Forenede Stater
      • Peoria, Illinois, Forenede Stater
    • Indiana
      • Evansville, Indiana, Forenede Stater
      • Indianapolis, Indiana, Forenede Stater
    • Kansas
      • Arkansas City, Kansas, Forenede Stater
      • Wichita, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • Michigan
      • Livonia, Michigan, Forenede Stater
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
    • New Jersey
      • Margate, New Jersey, Forenede Stater
    • New York
      • New Hyde Park, New York, Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
      • Raleigh, North Carolina, Forenede Stater
      • Statesville, North Carolina, Forenede Stater
      • Wilmington, North Carolina, Forenede Stater
      • Winston-Salem, North Carolina, Forenede Stater
    • Oregon
      • Medford, Oregon, Forenede Stater
    • Pennsylvania
      • Downingtown, Pennsylvania, Forenede Stater
      • Sellersville, Pennsylvania, Forenede Stater
      • Tipton, Pennsylvania, Forenede Stater
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
      • Mt. Pleasant, South Carolina, Forenede Stater
    • Tennessee
      • Bristol, Tennessee, Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
    • Utah
      • Ogden, Utah, Forenede Stater
    • Virginia
      • Norfolk, Virginia, Forenede Stater
      • Richmond, Virginia, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater

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:

  • Female participants of childbearing potential cannot be been pregnant, lactating and are not planning on becoming pregnant and agrees to use acceptable forms of contraception throughout the course of this study.
  • Must have a mean low-density lipoprotein cholesterol values between 3.367 and 5.689 mmol/L, inclusive, from 2 consecutive samples taken at least 1 week apart with the difference between the 2 values not exceeding 15% of the higher value.
  • Must have a triglyceride value of 4.516 mmol/L or less from 2 consecutive samples taken at least 1 week apart with the upper value from either sample being 5.081 mmol/L or less.
  • Has clinical laboratory evaluations within the reference ranges for the testing laboratory unless the results were deemed not clinically significant by the investigator or sponsor.
  • Is willing and able to maintain a standardized low-cholesterol diet.

Exclusion Criteria:

  • Has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
  • Has a serum creatinine level greater than 135 μmol/L.
  • Has a creatine phosphokinase value greater than three times the upper limit of normal.
  • Has diabetes mellitus type 1 or 2.
  • Has a history of cancer that had been in remission for less than 5 years prior to the first dose of study drug. This criterion did not include subjects with basal cell or stage I squamous cell carcinoma of the skin.
  • Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
  • Has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple risk factors that present a 10-year risk for CHD of greater than 20%, based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or participant's verbal report.
  • Has a positive human immunodeficiency virus test result or was taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Is unable or unwilling to discontinue excluded medications or to continue stable doses of "stable dose" medications or would require treatment with any excluded medication during the study.
  • Has had exposure to lapaquistat acetate in other studies or was participating or enrolled in another investigational study within the previous 30 days or, for drugs with a long half-life, within a period of less than 5 times the drug's half-life.
  • Has a history or presence of a clinically significant food allergy that would prevent adherence to the therapeutic lifestyle change (or equivalent) diet.
  • Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
  • Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
  • Has uncontrolled hypertension.
  • Has inflammatory bowel disease or any other malabsorption syndrome or had gastric bypass or any other surgical procedure for weight loss.
  • Has a history of drug abuse or alcohol abuse within the past 2 years.
  • Has any other serious disease or condition at Run-In or at Randomization that might reduce life expectancy, impair successful management according to the protocol, or make the subject an unsuitable candidate to receive study drug.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lapaquistat Acetat 100 mg QD
Medicin: Lapaquistat Acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks
Andre navne:
  • TAK-475
Placebo komparator: Placebo QD
Medicin: Placebo
Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Low-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit

Sekundære resultatmål

Resultatmål
Tidsramme
Change from Baseline in Calculated Low-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in High-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in the ratio of Low-Density Lipoprotein cholesterol/ High-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in Very Low-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in non- High-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Ændring fra baseline i triglycerider
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i totalt kolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Change from Baseline in the ratio of Total Cholesterol/High-Density Lipoprotein cholesterol
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Ændring fra baseline i apolipoprotein A1
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i apolipoprotein B
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Change from Baseline in the ratio of apolipoprotein B/ apolipoprotein A1
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Change from Baseline in High-Sensitivity C-reactive Protein
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

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.

Generelle publikationer

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. september 2005

Primær færdiggørelse (Faktiske)

1. april 2006

Studieafslutning (Faktiske)

1. april 2006

Datoer for studieregistrering

Først indsendt

31. august 2005

Først indsendt, der opfyldte QC-kriterier

31. august 2005

Først opslået (Skøn)

2. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. maj 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2012

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01-04-TL-475-008
  • U1111-1122-7722 (Registry Identifier: WHO)

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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