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Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia

23 maggio 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

224

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: OFFERTA Placebo
Droga: 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.
Sperimentale: Lapaquistat Acetate 100 mg QD (morning)
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475
Sperimentale: Lapaquistat Acetate 100 mg QD (evening)
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475
Sperimentale: Lapaquistat Acetate 50 mg BID
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475
Droga: 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.
Altri nomi:
  • TAK-475

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
Lasso di tempo: Week 6
Week 6

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Variazione percentuale rispetto al basale nel colesterolo lipoproteico ad alta densità
Lasso di tempo: Settimana 6
Settimana 6
Change from Baseline in Total Cholesterol
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in apolipoprotein B
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in apolipoprotein A1
Lasso di tempo: Week 6
Week 6
Change from Baseline in Triglycerides
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in derived ratio of Low-Density Lipoprotein Cholesterol / High-Density Lipoprotein Cholesterol
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in derived ratio of Total Cholesterol / High-Density Lipoprotein Cholesterol
Lasso di tempo: Week 6
Week 6
Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
Lasso di tempo: Week 6
Week 6
Change from Baseline in high sensitivity C-Reactive Protein.
Lasso di tempo: Week 6
Week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Takeda

Investigatori

  • Direttore dello studio: VP, Clinical Science, Takeda

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2007

Completamento primario (Effettivo)

1 novembre 2007

Completamento dello studio (Effettivo)

1 novembre 2007

Date di iscrizione allo studio

Primo inviato

18 marzo 2009

Primo inviato che soddisfa i criteri di controllo qualità

18 marzo 2009

Primo Inserito (Stima)

19 marzo 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 maggio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 maggio 2012

Ultimo verificato

1 maggio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAK-475_201
  • U1111-1122-8404 (Identificatore di registro: WHO)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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