EUCTR2018-004216-22-GB进行中（未招募）1 期
An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet 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
- 性别
- All
入选标准
- •The following are considered to be the Principal Inclusion Criteria for Study C602:
- •1) Successful completion of clinical study C601;
- •2) Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate);
- •3) Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
- •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 C602. Participants cannot enter C602 if not completed C601:
- •1) Anticipated requirement for use at any time during the study of the following prohibited medications:
- •Anti-obesity medications or other medications (including herbal preparations, over-the-counter products) or procedures for weight reduction;
- •Medications, including homeopathy and herbal preparations, that are strong inhibitors or inducers of CYP450 1A2 or 3A4 (Refer to http://medicine.iupui.edu/CLINPHARM/ddis/clinical-table, Flockhart Table);
- •Medications known to prolong the QTc interval (Refer to QT Drugs List on https://crediblemeds.org/healthcare-providers/), except citalopram and escitalopram;
- •Systemic steroids (i.e., oral, IM, or IV) for > 7 days;
- •Any drugs medications, herbal preparation, homeopathy, nutraceuticals, or procedures (i.e., acupuncture, vagal stimulation), that may have an effect on safety endpoints;
- •Use of any investigational drugs or devices;
- •2) Positive urine pregnancy test (in females of childbearing potential);
- •3) Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation;
- •4) Any new disease, condition, or circumstance, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol (e.g., an anticipated change of care setting);
- •5) New history in a first degree relative since the subject enrolled in clinical study C601 or a change in the subject’s physical examination that, in the opinion of the investigator, significantly increases the subject’s risk for thromboembolic event (e.g., venous thrombosis, pulmonary embolism, etc.).
研究者
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