An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 11
- 主要终点
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
研究概览
简要总结
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
- •Has completed the 7-month main trial, FE200486 CS42
排除标准
- •Has been withdrawn/discontinued from the FE200486 CS42 trial
- •A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.
研究组 & 干预措施
Degarelix
干预措施: Degarelix (Drug)
结局指标
主要结局
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
时间窗: From baseline (day 0) to end of treatment (up to day 364)
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
时间窗: From baseline (day 0) to end of treatment (up to day 364)
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Number of Participants With Markedly Abnormal Values in ECG Variables
时间窗: From baseline (day 0) to end of treatment (up to day 364)
This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
次要结局
- Serum Levels of Prostate Specific Antigen (PSA) Over Time(Day 0, day 196, day 280, and day 364)