EUCTR2013-005311-27-FI进行中（未招募）1 期
An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334
Amgen Inc.0 个研究点目标入组 651 人开始时间: 2015年1月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 651
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 parent study, and is appropriate for continued treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 651
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Development of any unstable or clinically significant medical condition, laboratory or ECG abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •2. Any subject who experienced an SAE in the parent study (AMG 334 20120295) for whom the investigator determined that there was a reasonable possibility that the event may have been caused by investigational medicinal product
- •3. In the opinion of the investigator, subject demonstrated poorly controlled hypertension following randomization into the parent study
- •4. Systolic blood pressure (BP) 150 mm Hg and/or diastolic BP 90 mm Hg or
- •greater at screening/Day 1
- •5. Pregnant (as confirmed by the Week 12 urine pregnancy test of parent study) or breastfeeding, or is a female expecting to conceive during the study, including through 16 weeks after the lst dose of investigational product
- •6. Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with AMG 334 through 16 weeks after the last dose of investigational product. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control
- •methods (pills, shots/injections, implants or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide
- •- males must use a condom with spermicide; females must choose either a Diaphragm with spermicide, OR Cervical cap with spermicide, OR Contraceptive sponge with spermicide
- •- refer to the protocol for a definition of female subjects not of childbearing potential
研究者
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