NCT01002222已完成3 期
Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAE)
研究概览
简要总结
This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.
详细描述
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a.
- •Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
排除标准
- •Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
- •Subject is considered ineligible for the study by the investigator(s).
研究组 & 干预措施
MCS-2
Experimental
干预措施: MCS-2 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAE)
时间窗: 36 weeks
次要结局
- Changes from baseline in International Prostate Symptom Score (I-PSS)(36 weeks)
- Changes from baseline in urine flow rate(36 weeks)
- Changes from baseline in serum lycopene levels(36 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract SymptomsLower Urinary Tract SymptomsBenign Prostatic HyperplasiaNCT01002274Health Ever Bio-Tech Co., Ltd.180
已完成
2 期
Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine CarcinomaNeuroendocrine CarcinomaNCT00663429Callisto Pharmaceuticals10
已完成
2 期
B0151005 Open-Label Extension StudyCrohn's DiseaseNCT01345318Pfizer191
终止
2 期
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03654755Asana BioSciences162
已完成
2 期
An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155Non-Hodgkin's LymphomaProstate CancerMelanomaNCT00818480Astellas Pharma Inc10