Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
23 de mayo de 2012 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
224
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Long Beach, California, Estados Unidos
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Sacramento, California, Estados Unidos
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San Diego, California, Estados Unidos
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Florida
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Hollywood, Florida, Estados Unidos
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Jacksonville, Florida, Estados Unidos
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New Port Richey, Florida, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Kansas
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Wichita, Kansas, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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New Jersey
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Margate, New Jersey, Estados Unidos
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North Carolina
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Charlotte, North Carolina, Estados Unidos
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Raleigh, North Carolina, Estados Unidos
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Statesville, North Carolina, Estados Unidos
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Wilmington, North Carolina, Estados Unidos
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Winston-Salem, North Carolina, Estados Unidos
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Oregon
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Medford, Oregon, Estados Unidos
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Pennsylvania
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Perkasie, Pennsylvania, Estados Unidos
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Sellerville, Pennsylvania, Estados Unidos
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Tennessee
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Bristol, Tennessee, Estados Unidos
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Virginia
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Norfolk, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Wisconsin
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Madison, Wisconsin, Estados Unidos
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: BID de placebo
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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.
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Experimental: Lapaquistat Acetate 100 mg QD (morning)
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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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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Experimental: Lapaquistat Acetate 100 mg QD (evening)
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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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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Experimental: Lapaquistat Acetate 50 mg BID
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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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
Periodo de tiempo: Week 6
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Week 6
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Cambio porcentual desde el inicio en el colesterol de lipoproteínas de alta densidad
Periodo de tiempo: Semana 6
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Semana 6
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Change from Baseline in Total Cholesterol
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein B
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein A1
Periodo de tiempo: Week 6
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Week 6
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Change from Baseline in Triglycerides
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in derived ratio of Low-Density Lipoprotein Cholesterol / High-Density Lipoprotein Cholesterol
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in derived ratio of Total Cholesterol / High-Density Lipoprotein Cholesterol
Periodo de tiempo: Week 6
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Week 6
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Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
Periodo de tiempo: Week 6
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Week 6
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Change from Baseline in high sensitivity C-Reactive Protein.
Periodo de tiempo: Week 6
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Week 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: VP, Clinical Science, Takeda
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de noviembre de 2007
Finalización del estudio (Actual)
1 de noviembre de 2007
Fechas de registro del estudio
Enviado por primera vez
18 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
18 de marzo de 2009
Publicado por primera vez (Estimar)
19 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de mayo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
23 de mayo de 2012
Última verificación
1 de mayo de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TAK-475_201
- U1111-1122-8404 (Identificador de registro: WHO)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .