NCT00780585已完成不适用
A Multi-center Cardiac Safety Study of Subjects Who Participated in Organon Sponsored Phase 1 and Phase 2 Completed and Discontinued Trials With Org 24448
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Overall cardiac function by cardiologist evaluation including echocardiogram.
研究概览
简要总结
This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.
详细描述
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must:
- •be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
- •sign an affirmative informed consent before evaluations are conducted;
排除标准
- •Subjects must not have:
- •a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.
研究组 & 干预措施
1
Subjects who participated in previous Org 24448 trials
干预措施: SCH 900460 (Drug)
结局指标
主要结局
Overall cardiac function by cardiologist evaluation including echocardiogram.
时间窗: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
次要结局
未报告次要终点
研究者
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