EUCTR2018-001317-33-IT进行中（未招募）1 期
A Phase II, open-label, ophthalmological external investigator-blinded, single-center, randomized, superiority, no profit, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy: the STAGO study - STUDIO STAGO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
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)Informed consent ; 2) A diagnosis of Graves’ disease; 3) A moderately severe Graves’ orbitopathy; 4) Active Graves’ orbitopathy; 5) No corticosteroids or immunosuppressive treatment for Graves’ orbitopathy in the last 3 months; 6) No previous surgical treatment for GO; 7) No contraindication to GC; 8) Male and female patients of age: 18-75 years; 9) LDL-cholesterol levels of 115-189 mg/dl; 10) No more than one cardiovascular risk factor; 11) Contraceptive method with a failure rate of less than 1% (patients of childbearing potential); 12) No mental illness ; 13) Compliant patient, regular follow-up possible
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1) lack of informed consent; 2) Absence of Graves’ hyperthyroidism; 3) inactive Graves’ orbitopathy; 4) Optic neuropathy; 5) Corticosteroids or immunosuppressive treatment in the last 3 months; 6) Previous surgical treatment for Graves’ orbitopathy; 7) Contraindications to glucocorticoids; 8) Pregnancy, breast-feeding women; 9) Acute or chronic liver disease; 10) Hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; 11) Medications interfering/interacting with statins; 12) Relevant Malignancy; 13) Recent (=1 year) history of alcoholism or drug abuse; 14) Clinical ASCVD (AthroSclerotic CardioVascular Disease); 15) LDL-cholesterol levels =190 mg/dl or presence of more than one associated cardiovascular risk factor;16) Severe familial hyperlipemia
研究者
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