EUCTR2018-004215-50-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
入选标准
- •The following are considered to be the Principal Inclusion Criteria for Study C601. The full list of study inclusion criteria is included in the study protocol.
- •a/. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subjects, as appropriate),
- •b/. Male and female subjects, 4 years of age and older
- •c/. Genetically-confirmed Prader-Willi syndrome and have hyperphagia
- •d/. In a stable care setting for at least 6 months prior to Visit 1.
- •e/. Caregiver must have been caring for the subject for at least 6 months prior to Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following are considered to be the Principal Exclusion Criteria for Study C601. The full list of study exclusion criteria is included in the study protocol.
- •- Weight < 20 kg or = 135 kg
- •- Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within 60 days prior to Visit 1
- •- Positive urine pregnancy test (in females of child-bearing potential)
- •- Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
- •- Any other known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol
研究者
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