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Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia

23. maj 2012 opdateret af: Takeda

A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in the Morning vs Lapaquistat Acetate 100 mg in the Evening vs Lapaquistat Acetate 50 mg Twice Daily vs Placebo in Subjects With Hypercholesterolemia

The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dyslipidemias are a group of metabolic disorders produced by raised concentrations of lipoproteins, especially low-density lipoprotein cholesterol the lipoprotein that transports endogenous cholesterol from the liver to the peripheral tissues. Increased cholesterol and triglyceride levels lead to an increased risk of arteriosclerosis, the underlying cause of heart attack, strokes and peripheral vascular disease. Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America.

Lapaquistat acetate is being developed by Takeda for the treatment of hypercholesterolemia.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

224

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Long Beach, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • San Diego, California, Forenede Stater
    • Florida
      • Hollywood, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • New Port Richey, Florida, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Kansas
      • Wichita, Kansas, Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater
    • New Jersey
      • Margate, New Jersey, 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
      • Perkasie, Pennsylvania, Forenede Stater
      • Sellerville, Pennsylvania, Forenede Stater
    • Tennessee
      • Bristol, Tennessee, 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:

  • Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Has prior to Randomization a mean low-density lipoprotein cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL for 2 consecutive samples.
  • Has prior to Randomization mean triglycerides less than 400 mg/dL for 2 consecutive samples.
  • Is willing and able to comply with a standardized, therapeutic lifestyle change diet or equivalent.

Exclusion Criteria:

  • Has an alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of normal during the screening period.
  • Has a serum creatinine greater than133 mmol/L during the screening period.
  • Has a creatine phosphokinase greater than 3 times the upper limit of normal, identified during the screening period.
  • Has active liver disease or jaundice.
  • Has a history of cancer that has 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, unstable angina, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdomin al aorticaneurysm, coronary angioplasty, coronary or peripheral arterial surgery or multiple risk factors that confer a 10-year risk for cardiovascular 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 is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Has received any investigational compound within 30 days prior to screening Visit 1, or is currently participating in another investigational study.
  • Has received lapaquistat acetate in a previous clinical study or as a therapeutic agent.
  • Has a history or presence of clinically significant food allergy that would prevent adherence to the specialized diet.
  • Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia.
  • Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
  • Has uncontrolled hypertension despite treatment at Screening Visit 1.
  • Has had inflammatory bowel or any other malabsorption syndrome or has 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 stage I squamous cell carcinoma of the skin.
  • Has type 1 or type 2 diabetes mellitus.

  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

    • Fluvastatin
    • Lovastatin
    • bile acid sequestrants (eg, cholestyramine)
    • intestinal cholesterol uptake inhibitors (eg, ezetimibe)
    • Fibrates (eg, fenofibrate, gemfibrozil)
    • Niacin
    • Cholestin
    • red yeast rice
    • fish oils
    • plant sterols and stanols
    • orlistat
    • sibutramine
    • isotretinoin
    • tacrolimus
    • Probucol
    • Systemic corticosteroids and androgens
    • Potent CYP3A4 inhibitors
    • Cyclosporine
    • Erythromycin
    • Clarithromycin
    • Telithromycin
    • human immunodeficiency virus protease inhibitors
    • amiodarone
    • diltiazem
    • verapamil
    • nefazodone
    • grapefruit juice

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
Placebo komparator: Placebo BID
Medicin: Placebo
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Eksperimentel: Lapaquistat Acetate 100 mg QD (morning)
Medicin: Lapaquistat acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Eksperimentel: Lapaquistat Acetate 100 mg QD (evening)
Medicin: Lapaquistat acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Eksperimentel: Lapaquistat Acetate 50 mg BID
Medicin: Lapaquistat acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475
Medicin: Lapaquistat acetate
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Andre navne:
  • TAK-475

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
Tidsramme: Week 6
Week 6

Sekundære resultatmål

Resultatmål
Tidsramme
Procentvis ændring fra baseline i High-Density Lipoprotein Cholesterol
Tidsramme: Uge 6
Uge 6
Change from Baseline in Total Cholesterol
Tidsramme: Week 6
Week 6
Percent change from Baseline in apolipoprotein B
Tidsramme: Week 6
Week 6
Percent change from Baseline in apolipoprotein A1
Tidsramme: Week 6
Week 6
Change from Baseline in Triglycerides
Tidsramme: Week 6
Week 6
Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
Tidsramme: Week 6
Week 6
Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
Tidsramme: Week 6
Week 6
Percent change from Baseline in derived ratio of Low-Density Lipoprotein Cholesterol / High-Density Lipoprotein Cholesterol
Tidsramme: Week 6
Week 6
Percent change from Baseline in derived ratio of Total Cholesterol / High-Density Lipoprotein Cholesterol
Tidsramme: Week 6
Week 6
Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
Tidsramme: Week 6
Week 6
Change from Baseline in high sensitivity C-Reactive Protein.
Tidsramme: Week 6
Week 6

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

Efterforskere

  • Studieleder: VP, Clinical Science, Takeda

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. juli 2007

Primær færdiggørelse (Faktiske)

1. november 2007

Studieafslutning (Faktiske)

1. november 2007

Datoer for studieregistrering

Først indsendt

18. marts 2009

Først indsendt, der opfyldte QC-kriterier

18. marts 2009

Først opslået (Skøn)

19. marts 2009

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

  • TAK-475_201
  • U1111-1122-8404 (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

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner