EUCTR2013-005311-27-DE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: 2014年4月2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
- •- 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
- •- 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
- •- In the opinion of the investigator, subject demonstrated poorly controlled
- •hypertension following randomization into the parent study
- •- Systolic blood pressure (BP) 150 mm Hg and/or diastolic BP 90 mm Hg or
- •greater at screening/Day 1
- •- 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 last dose of investigational product
- •- 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 pocedure 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 deinition of female subjects not of childbearing potential
研究者
相似试验
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesPrevention of chronic migraineMedDRA version: 19.1Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852EUCTR2013-005311-27-FIAmgen Inc.651
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesPrevention of chronic migraineMedDRA version: 17.0Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852EUCTR2013-005311-27-NOAmgen Inc.609
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2013-005311-27-SEAmgen Inc.651
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesPrevention of chronic migraineMedDRA version: 19.0Level: LLTClassification code 10027608Term: Migraine, unspecifiedSystem Organ Class: 100000004852EUCTR2013-005311-27-PLAmgen Inc.651
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2013-005311-27-CZAmgen Inc.490