EUCTR2013-005311-27-CZ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 490 人开始时间: 2014年10月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 490
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 490
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 224
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 withthe 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 last dose of investigational
- •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
- •- 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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