EUCTR2006-003107-39-GB进行中（未招募）1 期
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin - Effect of an Investigational Compound on Tolerability of Extended Release Niacin
Merck Sharp & Dohme Limited0 个研究点目标入组 825 人开始时间: 2006年8月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 825
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
- •Patient is male or female, aged 18 to 70 years.
- •Female patients of reproductive potential agree to be abstinent or to use 2 acceptable methods of birth control for duration of study. Acceptable defined as IUD, diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
- •Patient is appropriate candidate for niacin therapy.
- •Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1.
- •Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1.
- •Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1.
- •Patient has TG <500 mg/dL (5.65 mmol/L) at V1.
- •A patient’s historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria.
- •ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA.
- •Glycemic status of patient has been determined prior to visit 2.
- •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
- •Patients with unstable doses of medications.
- •Pregnant or lactating women, or women intending to become pregannt are excluded.
- •Patients with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
- •Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year).
研究者
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