EUCTR2015-000493-35-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneouslyto Patients with Familial Partial Lipodystrophy - The BROADEN Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
- •1. Clinical diagnosis of FPL plus diagnosis of type 2 diabetes mellitus and
- •hypertriglyceridemia.
- •2.Diagnosis of Type 2 diabetes mellitus as defined by the ADASMCD in
- •2015 made at least 12 weeks prior to the screening visit
- •3. Hypertriglyceridemia is defined as Fasting TG = 500 mg/dL (= 5.7
- •mmol/L) at Screening and qualification visit.
- •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 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. A diagnosis of generalized lipodystrophy
- •2. A diagnosis of acquired partial lipodystrophy (APL)
- •3. Acute pancreatitis within 4 weeks of Screening
- •4. History within 6 months of Screening of acute or unstable cardiac
- •ischemia (myocardial infarction, acute coronary syndrome, new onset
- •angina), stroke, transient ischemic attack or unstable congestive heart
- •failure requiring a change in medication
- •5. Major surgery within 3 months of Screening
- •6. Platelet count 7. Have any other conditions in the opinion of the investigator which
- •could interfere with the patient participating in our completing the study
研究者
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