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Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia

23 mei 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

224

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Long Beach, California, Verenigde Staten
      • Sacramento, California, Verenigde Staten
      • San Diego, California, Verenigde Staten
    • Florida
      • Hollywood, Florida, Verenigde Staten
      • Jacksonville, Florida, Verenigde Staten
      • New Port Richey, Florida, Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten
    • Kansas
      • Wichita, Kansas, Verenigde Staten
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten
    • New Jersey
      • Margate, New Jersey, Verenigde Staten
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten
      • Raleigh, North Carolina, Verenigde Staten
      • Statesville, North Carolina, Verenigde Staten
      • Wilmington, North Carolina, Verenigde Staten
      • Winston-Salem, North Carolina, Verenigde Staten
    • Oregon
      • Medford, Oregon, Verenigde Staten
    • Pennsylvania
      • Perkasie, Pennsylvania, Verenigde Staten
      • Sellerville, Pennsylvania, Verenigde Staten
    • Tennessee
      • Bristol, Tennessee, Verenigde Staten
    • Virginia
      • Norfolk, Virginia, Verenigde Staten
      • Richmond, Virginia, Verenigde Staten
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo BID
Geneesmiddel: 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.
Experimenteel: Lapaquistat Acetate 100 mg QD (morning)
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Experimenteel: Lapaquistat Acetate 100 mg QD (evening)
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Experimenteel: Lapaquistat Acetate 50 mg BID
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475
Geneesmiddel: 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.
Andere namen:
  • TAK-475

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Procentuele verandering ten opzichte van de uitgangswaarde in High-Density Lipoprotein Cholesterol
Tijdsspanne: Week 6
Week 6
Change from Baseline in Total Cholesterol
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in apolipoprotein B
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in apolipoprotein A1
Tijdsspanne: Week 6
Week 6
Change from Baseline in Triglycerides
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in derived ratio of Low-Density Lipoprotein Cholesterol / High-Density Lipoprotein Cholesterol
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in derived ratio of Total Cholesterol / High-Density Lipoprotein Cholesterol
Tijdsspanne: Week 6
Week 6
Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
Tijdsspanne: Week 6
Week 6
Change from Baseline in high sensitivity C-Reactive Protein.
Tijdsspanne: Week 6
Week 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Onderzoekers

  • Studie directeur: VP, Clinical Science, Takeda

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2007

Primaire voltooiing (Werkelijk)

1 november 2007

Studie voltooiing (Werkelijk)

1 november 2007

Studieregistratiedata

Eerst ingediend

18 maart 2009

Eerst ingediend dat voldeed aan de QC-criteria

18 maart 2009

Eerst geplaatst (Schatting)

19 maart 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

24 mei 2012

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2012

Laatst geverifieerd

1 mei 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TAK-475_201
  • U1111-1122-8404 (Register-ID: WHO)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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