EUCTR2004-002549-11-FI进行中（未招募）不适用
An Open-label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar 1 mg in patients with Type 2 Diabetes. - GALLEX 1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
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.Provision of a written informed consent at visit 1
- •2.Men and women with type 2 diabetes who have completed the last two visits of randomized treatment period in GALLANT 2, 5, 7, 8 and 14 studies
- •3.Female patients must be post menopausal, hysterectomised or if of childbearing potential using a highly effective method of birth control.
- •Post menopausal patients are defined as patients with:
- •-natural or induced menopause with last menstruation >1 year ago or
- •-bilateral oophorectomy
- •Highly effective birth control is defined as:
- •-double-barrier method (condoms with spermicide, diaphragm with spermicide),
- •-oral contraceptive, implant, long term injectable contraceptive,
- •-intrauterine device, or
- •-tubal ligation.
- •However, female patients using oestrogen containing hormonal anti conception method (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
- •- NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. For definitions see Appendix F.
- •- History of thyroid ophthalmopathy
- •- History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
- •- History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis
- •- Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. See Appendix G.
- •- History of statin-induced myopathy or statin-induced CK elevation
- •- History of alcohol or drug abuse within the last 5 years
- •- Patient currently in any of the handling plans at the end of randomized treatment visit in the GALLANT 2, 5, 7, 8 or 14 studies
研究者
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