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Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia

23. maj 2012 opdateret af: Takeda

A Double-Blind, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy and Safety of Lapaquistat and Simvastatin Alone and in Combination in Subjects With Hypercholesterolemia

The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with simvastatin on cholesterol levels in treating patients with elevated cholesterol.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Patients with hypercholesterolemia have elevated low-density lipoprotein cholesterol, which leads to atherosclerotic deposition of cholesterol in the arterial walls. As identified by the National Cholesterol Education Program Adult Treatment Panel III, lowering the low-density lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity and mortality and is essential for the prevention and management of coronary heart disease.

Currently, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) are the first-line monotherapies prescribed to reduce low-density lipoprotein cholesterol, after diet and therapeutic lifestyle change. However, low doses of statins often fail to produce the ATP III-recommended levels of low-density lipoprotein cholesterol reduction, making it necessary to increase the dose or add an additional treatment. Dose increases of statins in turn may result in decreased tolerability and potential safety concerns which contribute to the high discontinuation rates of statins and their prescription at low, and often ineffective, doses.

The purpose of this study is to determine whether administration of lapaquistat acetate co-administered with simvastatin will be more efficacious in lowering low-density lipoprotein cholesterol, compared to lapaquistat or simvastatin alone. Total participation time in this study is anticipated to be 19 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1362

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada
      • Coquitlam, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
      • St. John's, Newfoundland and Labrador, Canada
    • Ontario
      • Cornwall, Ontario, Canada
      • London, Ontario, Canada
      • Oakville, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
    • Prince Edward Island
      • Cornwall, Prince Edward Island, Canada
    • Quebec
      • Mirabel, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • St. Lambert, Quebec, Canada
      • Ste-Foy, Quebec, Canada
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater
      • Scottsdale, Arizona, Forenede Stater
      • Sierra Vista, Arizona, Forenede Stater
      • Tucson, Arizona, Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater
      • Long Beach, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • Spring Valley, California, Forenede Stater
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater
    • Florida
      • Hialeah, Florida, Forenede Stater
      • Hollywood, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Jupiter, Florida, Forenede Stater
      • Kissimmee, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Ocala, Florida, Forenede Stater
      • Pembroke Pines, Florida, Forenede Stater
      • Pinellas Park, Florida, Forenede Stater
      • Stuart, Florida, Forenede Stater
      • West Palm Beach, Florida, Forenede Stater
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater
      • Chicago, Illinois, Forenede Stater
      • Peoria, Illinois, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Kansas
      • Overland Park, Kansas, Forenede Stater
      • Wichita, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • Minnesota
      • Edina, Minnesota, Forenede Stater
    • Missouri
      • St. Louis, Missouri, Forenede Stater
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
    • New Jersey
      • Margate City, New Jersey, Forenede Stater
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater
      • Statesville, North Carolina, Forenede Stater
      • Winston-Salem, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Columbus, Ohio, Forenede Stater
      • Kettering, Ohio, Forenede Stater
    • Oklahoma
      • Bartlesville, Oklahoma, Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater
      • Downingtown, Pennsylvania, Forenede Stater
      • Tipton, Pennsylvania, Forenede Stater
    • South Carolina
      • Goose Creek, South Carolina, Forenede Stater
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • San Antonio, Texas, Forenede Stater
    • Virginia
      • Norfolk, Virginia, Forenede Stater
      • Richmond, Virginia, Forenede Stater
    • Washington
      • Lakewood, Washington, 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:

  • Woman of childbearing potential can not to be pregnant, lactating, not planning on becoming pregnant, and agree to use acceptable forms of contraception throughout the course of the study.
  • Prior to Randomization, has a low-density lipoprotein cholesterol level mean greater than or equal to 3.37 mmol/L and less than or equal to 5.70 mmol/L.
  • Prior to Randomization, has a mean triglyceride level less than or equal to 4.52 mmol/L (400 mg/dL).
  • Has clinical laboratory evaluations including clinical chemistry, hematology, and urinalysis within the defined reference range.

Exclusion Criteria:

  • Has an alanine aminotransferase or aspartate aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
  • Has a serum creatinine of greater than 133 μmol/L.
  • Has a creatine kinase greater than 3 times the upper limit of normal.
  • Has type 1 or 2 diabetes mellitus.
  • Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
  • 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 factors that conferred a 10-year risk for coronary heart disease greater than 20% based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen, or antibody to hepatitis C virus, as determined by medical history and/or subject's verbal report.
  • Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history.
  • Has exposure to lapaquistat acetate in other studies, was participating in another investigational study, or had participated in an investigational study within the past 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 known hypersensitivity or history of adverse reaction to simvastatin.
  • Has a known hypersensitivity or history of adverse reaction to simvastatin.
  • Has a history or presence of clinically significant food allergy that would prevent adherence to the recommended 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, any other malabsorption syndrome, or had gastric bypass or any other surgical procedure for weight loss.
  • Is unwilling or unable, in the opinion of the investigator, to comply with the protocol or scheduled appointments.
  • Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
  • Has any other serious disease or condition that might reduced life expectancy, impaired successful management according to the protocol, or make the participant an unsuitable candidate to receive study medication.

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: Faktoriel opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Simvastatin
Medicin: Simvastatin
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Andre navne:
  • Zocor
Eksperimentel: Lapaquistat Acetat 50 mg QD + Simvastatin
Medicin: Lapaquistat acetate and simvastatin
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Andre navne:
  • Zocor
  • TAK-475
Medicin: Lapaquistat acetate and simvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Andre navne:
  • Zocor
  • TAK-475
Eksperimentel: Lapaquistat Acetat 100 mg QD + Simvastatin
Medicin: Lapaquistat acetate and simvastatin
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Andre navne:
  • Zocor
  • TAK-475
Medicin: Lapaquistat acetate and simvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks.
Andre navne:
  • Zocor
  • TAK-475

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring fra baseline i lavdensitetslipoproteinkolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg

Sekundære resultatmål

Resultatmål
Tidsramme
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
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
Ændring fra baseline i non-High Density Lipoprotein kolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i High Density Lipoprotein kolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i meget lavdensitetslipoproteinkolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i forholdet mellem totalt kolesterol og højdensitetslipoproteinkolesterol
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i forholdet mellem apolipoprotein A1/apolipoprotein B
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Ændring fra baseline i højfølsomt C-reaktivt protein
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Procentdel af forsøgspersoner, der opnår Low Density Lipoprotein-kolesterolkoncentrationer på mindre end 2,59 mmol/L (100 mg/dL)
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Procentdel af forsøgspersoner, der opnår Low Density Lipoprotein-kolesterolkoncentrationer på mindre end 3,37 mmol/L (130 mg/dL)
Tidsramme: Uge 12 eller sidste besøg
Uge 12 eller sidste besøg
Adverse Events
Tidsramme: Weeks: 2, 4, 8, and 12 or Final Visit
Weeks: 2, 4, 8, and 12 or Final Visit
Physical Examination
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Safety Laboratory Tests
Tidsramme: Weeks: 2, 4, 8, and 12 or Final Visit
Weeks: 2, 4, 8, and 12 or Final Visit
12- lead Electrocardiogram assessments
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Best Corrected Visual Acuity results
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Vital Signs
Tidsramme: Weeks: 2, 4, 8, and 12 or Final Visit
Weeks: 2, 4, 8, and 12 or Final Visit
Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density
Tidsramme: Week 12 or Final Visit
Week 12 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 4.14 mmol/L (160 mg/dL)
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. marts 2006

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

1. februar 2006

Først indsendt, der opfyldte QC-kriterier

1. februar 2006

Først opslået (Skøn)

3. februar 2006

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

  • 01-05-TL-475-020
  • U1111-1122-7978 (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 .

Kliniske forsøg med Lapaquistat acetate and simvastatin

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