PLASMA 2 Trial: Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease (PLASMA 2)
3 de enero de 2008 actualizado por: Anthera Pharmaceuticals
Phospholipase Levels And Serological Markers of Atherosclerosis 2: An Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease
The study will be conducted at up to 25 U.S. centers and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD).
Subjects will be randomized to receive either placebo tablets or one of 2 orally active doses of A-002.
The duration of study drug therapy will be 8 weeks.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD).
Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process.
Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk.
Recent clinical studies have provided a strong association between levels and cardiovascular event risk.
The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2222) will examine the effects of 2 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment.
In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
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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Alabama
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Mobile, Alabama, Estados Unidos, 36608
- Mobile Heart Specialists
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85260
- Sonoran Health Specialists
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Florida
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Hudson, Florida, Estados Unidos, 34667
- Pasco Cardiology Center
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Port Charlotte, Florida, Estados Unidos, 33952
- Charlotte Cardiovascular Institute
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Tampa, Florida, Estados Unidos, 33609
- Florida Cardiovascular Research Institute
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Georgia
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Augusta, Georgia, Estados Unidos, 30901
- Augusta Cardiology Clinic
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Louisville Cardiology Medical Group
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Maine
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Auburn, Maine, Estados Unidos, 04210
- Maine Research Associates
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New York
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Binghamton, New York, Estados Unidos, 13901
- United Medical Associates
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Syracuse, New York, Estados Unidos, 13210
- Cardiology PC
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Texas
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Austin, Texas, Estados Unidos, 78705
- Austin Heart
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Clinical Research Associates of Tidewater
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53715
- Wisconsin Heart, SC
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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:
Subjects are eligible for inclusion if they meet the following inclusion criteria:
- Men and women ≥18 years of age
- Written informed consent from the subject
- Stable CAD
- Stable medical condition, will be compliant and able to comply with the requirements of the protocol
Exclusion Criteria:
Subjects must NOT meet any of the following exclusion criteria:
- Planned coronary artery bypass surgery (CABG)
- Acute or chronic heart failure as defined by the New York Heart Association (NYHA) classification as functional Class III or Class IV
- Hospitalization for acute coronary syndrome (ACS) if troponin >0.1 ng/mL in the preceding 6 weeks
- Hospitalization for ST-segment elevation acute myocardial infarction (STEMI) in the preceding 12 weeks
- Subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
- hs-CRP ≥15 mg/L repeated on at least 2 occasions >24 hours apart due to non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)
- Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening or prior experience with A-002.
- Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision (e.g., chemotherapy), or radiation therapy
- Subjects who have received immunosuppressant therapy within 30 days prior to entry
- Subjects who have received anti-tumor necrosis factor (for example, infliximab) therapy within 6 months prior to entry
- The presence of severe liver disease with cirrhosis, recent active hepatitis, active chronic hepatitis, ALT or AST >3 x upper limit of normal, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x upper limit of normal)
- Active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities
- The presence of moderate or severe renal impairment (CrCl <60 mL/min or creatinine >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis
- Uncontrolled diabetes mellitus (known HbA1c >11% within the last 1 month prior to screening)
- Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or subjects who have a positive serum pregnancy test at Visit 1 (if the subject is a female of child-bearing potential). Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom).
- Subjects who have a history of alcohol or drug abuse within 1 year of study entry
- Subject living too far from participating center or unable to return for follow-up visits
- Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
- Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C Virus (HCV) infection
- Treatment with any systemic corticosteroid within the 30-day period prior to study entry or the use of inhaled steroids within the 14-day period prior to study entry
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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The primary objective of this study is to determine the effect of once daily (QD) dosing of A-002 on sPLA2 levels and activity
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Medidas de resultado secundarias
Medida de resultado |
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Determine the effect of QD dosing of A-002 on sPLA2 levels and activity at each time point (Weeks 2, 4, and 8)
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Compare the effect of QD dosing of A-002 on sPLA2 enzyme levels and markers of inflammation
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Determine plasma drug concentrations with QD dosing
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 septiembre de 2007
Finalización del estudio
1 de diciembre de 2007
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
5 de septiembre de 2007
Publicado por primera vez (Estimar)
6 de septiembre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de enero de 2008
Última actualización enviada que cumplió con los criterios de control de calidad
3 de enero de 2008
Última verificación
1 de enero de 2008
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AN-CVD2222
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. .