NCT01173471已完成2 期
A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR
- •Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication
- •Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP
- •Placebo treatment for duration of the study must not be considered detrimental to the patient
排除标准
- •Have uncontrolled intra-ocular hypertension (>36 mmHg)
- •Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect)
- •Have had severe eye trauma at any time
研究组 & 干预措施
1) AZD4017
Experimental
Europe: 200 mg AZD4017
干预措施: AZD4017 (Drug)
2) Placebo
Placebo Comparator
Europe: placebo
干预措施: Placebo (Drug)
3) AZD4017
Experimental
USA: 800 mg AZD4017
干预措施: AZD4017 (Drug)
4) Placebo
Placebo Comparator
USA: placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
时间窗: Baseline to 4 weeks
次要结局
- Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment(Baseline to 4 weeks)
- Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment(Baseline to 4 weeks)
研究者
研究点 (1)
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