EUCTR2007-003684-41-DE进行中（未招募）不适用
AMulticenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Assess the Efficacy and Tolerability of MK-6213 Co-Administered with Atorvastatin in Patients with Primary Hypercholesterolemia
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
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.Patient is male or female and 18 to 75 years of age on day of signing informed consent.
- •2.A female patient who is not of reproductive potential without requiring the use of contraception. A female patient who is not of reproductive potential is defined as: one who has either 1) reached naturalmenopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined bythe laboratory, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomywith or without hysterectomy, or 3) bilateral tubal ligation.
- •3. A female of reproductive potential who agrees to take acceptable contraceptive precautions for the duration of the study.
- •Examples of acceptable contraception may include:
- •abstinence
- •use of 2 methods of birth control for the duration of the study including intrauterine device (IUD), diaphragm with spermicide, cervical cap, vaginal sponge, condom
- •vasectomy (male partner)
- •exclusive homosexual relationship
- •Note: A successful vasectomyis defined as: (a) microscopic documentation of azoospermia, or (b) greater than 2 yearsago with no resultant pregnancydespite sexual activitypost vasectomy
- •4.Patient is classified as low risk” (0-1 risk factors) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-190 mg/dL (2.6–4.9 mmol/L)
- •5.Patient is classified as moderate risk” (2 or more risk factors and 10 year CHD risk<10%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-160 mg/dL (2.6–4.1 mmol/L)
- •6.Patient is classified as moderate-high risk” (10-yr CHD risk 10-20%) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with
- •an off-treatment LDL-C value of 100-145 mg/dL (2.6–3.6 mmol/L)
- •or, off-treatment LDL-C 100-130 mg/dL (2.6–3.4 mmol/L) if patient was taking lipid therapy more potent than atorvastatin 10 mg at the time of screening (See Appendix 6.3)
- •7.Diabetic patients NOTtaking lipid-lowering medication, with LDL-C 100-130 mg/dL (2.6–3.4 mmol/L),with<2 other cardiovascular risk factors, and without microalbuminuria who meet all other entrycriteria are eligible (see Section 2.3 Patient Exclusion Criteria (h).
- •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
- •Patient has a history of secondary hypertension (high blood pressure), cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease. Patient has a history of mental instability or drug/alcohol abuse within the past 5 years. Patient drinks more than 2 alcoholic drinks per day. Patient is pregnant or nursing. Patient is HIV positive. Patient has a history of cancer within the past 5 years. Patient has been in a investigational trial within the last 30 days
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