Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 346
- 主要终点
- Number of Participants Who Discontinued Treatment Due to an Adverse Event
研究概览
简要总结
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
- •completed Protocol P05706 or P05707;
- •Have safety and efficacy assessments conducted per protocol P05706 or P05707.
排除标准
- •clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
- •clinically relevant abnormal laboratory values as judged by the investigator;
- •any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
- •were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
研究组 & 干预措施
Esmirtazapine
One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks
干预措施: Org 50081 (Drug)
结局指标
主要结局
Number of Participants Who Discontinued Treatment Due to an Adverse Event
时间窗: Up to 52 weeks
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.
Number of Participants With an Adverse Event
时间窗: Up to 57 weeks
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.
次要结局
- Change From Baseline in Number of Awakenings at Week 52(Baseline and Week 52)
- Change From Baseline in Quality of Sleep Scale at Week 52(Baseline and Week 52)
- Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52(Baseline and Week 52)
- Change From Baseline in Sleep Latency at Week 52(Baseline and Week 52)
- Change From Baseline in Total Sleep Time at Week 52(Baseline and Week 52)
- Change From Baseline in Wake Time After Sleep Onset at Week 52(Baseline and Week 52)