NCT00038662已完成2 期
A Phase 2 Study Evaluating the Safety and Efficacy of Atrasentan (ABT-627) in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 200
- 试验地点
- 78
- 主要终点
- Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
研究概览
简要总结
The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate adenocarcinoma,
- •radical prostatectomy,
- •PSA between 0.4 and 5 ng/mL,
- •PSADT < 1 year
排除标准
- •previous hormonal therapy,
- •salvage therapy to the pelvis within 3 months prior to randomization
结局指标
主要结局
Evaluate the safety and efficacy of 10mg atrasentan in hormone naive subjects, as measured by the rate of rise in PSA.
次要结局
未报告次要终点
研究者
研究点 (78)
Loading locations...
相似试验
招募中
2 期
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem CellsChronic Obstructive Pulmonary DiseaseNCT06491043Meribank Biotech Co., Ltd.90
终止
2 期
A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic PainNCT05895552Reata, a wholly owned subsidiary of Biogen209
终止
2 期
Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose ToleranceCystic FibrosisNCT02955888Liminal BioSciences Ltd.11
已完成
2 期
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) PatientsCystic FibrosisNCT02443688Celtaxsys, Inc.200
已完成
2 期
A Study of RBD1016 in CHB ParticipantsNCT05961098Suzhou Ribo Life Science Co. Ltd.48