A PHASE III OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF ARD-0403

ARD-0403 功效和安全性的 III 期开放标签研究

• 批准号: 7952253
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 13.12万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952253
• 关键词: Adverse event; Androgens; Biochemistry; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Electrocardiogram; Enrollment; Funding; Grant; Hematology; Hormones; Informed Consent; Institution; Laboratories; Maintenance; Patients; Pharmaceutical Preparations; Phase; Physical Examination; Process; Prostate; Reaction; Research; Research Personnel; Resources; Safety; Serious Adverse Event; Serum; Site; Source; Testosterone; Titrations; United States National Institutes of Health; digital; men; open label; rectal; safety study; treatment duration

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. This is a phase III, open-label, dose-titration, multi-center study. Titration is defined as the process of gradually adjusting the dose of a medication until the desired effect is achieved. Up to 150 testosterone deficient men are expected to enter this study. Each of them will receive 28 daily applications of 2.25g ARD-0403. After 28 days of treatment, if testosterone levels are not within the reference 300- 700 ng/dL), the dose of ARD-0403 will be titrated, if serum testosterone levels are below 300 ng/dl, the dose will be increased by 2.25g to 4.5g and if the level is above 700 ng/dl, the dose will be decreased to 1.5 g. Further dose titrations may be made prior to patients entering a 12 week maintenance phase. Prior to participation in the study, potential subjects will undergo an "inclusion phase" to determine whether they are eligible for the study. This phase will include the informed consent process, washout of current androgen treatment (if applicable), physical examination (including a digital rectal exam to check prostate size), an electrocardiogram (ECG), safety laboratory assessments (consisting of PSA, hematology, and serum hormone levels). Subjects need to have documented serum total testosterone levels <250ng/dL on at least two occasions prior to enrolling into the study. Safety of the study drug will be assessed by evaluating the collected safety data of adverse events, serious adverse events (SAEs), ECG, vital signs, application site reactions and clinical laboratory parameters (biochemistry and hematology).

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。 这是一项III期，开放标签的，剂量折线，多中心研究。 滴定被定义为逐渐调整药物剂量的过程，直到达到所需的效果为止。 预计多达150个睾丸激素不足的男性将进入这项研究。 他们每个人将收到28个每日2.25G ARD-0403的申请。 经过28天的治疗后，如果睾丸激素水平不在参考300-700 ng/dl）中，则ARD-0403的剂量将滴定，如果血清睾丸激素水平低于300 ng/dl，则剂量将增加2.25g至4.5G，并且如果水平高于700 ng/dL/dg/dl，则降低了DOSE，DOSE降低为1.5 g 1.5 g。 在进入12周维护阶段的患者之前，可以进一步进行剂量滴定。 在参与研究之前，潜在的受试者将经历“包容阶段”，以确定他们是否有资格参加研究。该阶段将包括知情同意过程，当前的雄激素治疗（如果适用），体格检查（包括检查前列腺大小的数字直肠检查），心电图（ECG），安全实验室评估（PSA，血液学和血清激素水平）。 受试者需要至少两次记录血清总睾丸激素水平<250ng/dl。 研究药物的安全将通过评估不良事件，严重不良事件（SAE），心电图，生命体征，应用部位反应和临床实验室参数（生物化学和血液学）的收集安全数据来评估。