A PILOT STUDY OF THE SAFETY, EFFICACY, AND TOLERABILITY OF EZETIMIBE (ZETIA?)

依泽替米贝 (Zetia?) 安全性、有效性和耐受性的试点研究

• 批准号: 7606477
• 负责人: MICHAEL P DUBE
• 金额: $ 0.76万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606477
• 关键词: Age-Years; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Daily; Double-Blind Method; Enrollment; Evaluation Studies; Funding; Grant; Highly Active Antiretroviral Therapy; Institution; LDL Cholesterol Lipoproteins; Laboratories; Oral cavity; Pilot Projects; Placebo Control; Questionnaires; Randomized; Recording of previous events; Research; Research Design; Research Personnel; Resources; Safety; Schering-Plough brand of ezetimibe; Source; Testing; United States National Institutes of Health; Visit; Week; Woman; day; ezetimibe; men

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5209 is a double-blind, randomized, placebo-controlled, crossover study designed to determine the safety, efficacy, and tolerability of ezetimibe (Zetia) therapy in combination with ongoing statin therapy in HIV-infected subjects with elevated LDL cholesterol. HIV-infected men and women > 18 years of age on highly active antiretroviral therapy (HAART) and statin therapy for at least 3 months prior to study entry and on stable statin and HAART for at least 30 days prior to study entry and with elevated low-density lipoprotein cholesterol (LDL-c) >130 mg/dL will be enrolled. A total of 43 subjects will have 9 study visits over a 28- week period. Subjects will receive ezetimibe 10 mg by mouth once daily for 12 weeks. Study evaluations include history and physical exams, laboratory testing, and questionnaires.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 A5209是一项双盲，随机，安慰剂对照的跨界研究，旨在确定ezetimibe（Zetia）治疗的安全性，有效性和耐受性，以及在HIV感染的受试者中持续的他汀类药物治疗，LDL胆固醇升高。 在研究入学前至少3个月，至少3个月，至少3个月，在研究入学前至少30天，至少3个月内，至少3个月，至少3个月，在高度活跃的抗逆转录病毒疗法（HAART）和他汀类药物疗法中，艾滋病毒感染的男性和女性至少3个月，并且低密度脂蛋白胆固醇（LDL-C）> 130 mg/dl将供应。在28周期间，共有43名受试者将进行9次学习访问。 受试者每天将每天1毫克的ezetimibe接受10毫克，持续12周。研究评估包括历史和体格检查，实验室测试和问卷调查。