EUCTR2006-002911-28-NL进行中（未招募）1 期
A multicentre, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study to evaluate the efficacy, safety and tolerability of once daily oral dosing of GW501516 (2.5 mg, 5 mg and 10 mg) over 12 weeks in subjects withprimary hypercholesterolemia on background statin therapy.
GlaxoSmithKline R&D0 个研究点目标入组 0 人开始时间: 2006年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Male or female subjects aged 18-70 years (inclusive at the time of Pre- Screening
- •2. Subjects who are on stable, approved dose of Simvastatin (20, 40 or 80 mg) or
- •Atorvastatin (10, 20, 40 or 80 mg) for a minimum of 8 Weeks prior to the prescreening visit 1.
- •3. Subjects with stable LDL-C =100 mg/dl (2.59 mmol/L) and =160 mg/dL (4.14
- •mmol/L) at Visits 1 and 2
- •4. Females, to be eligible to enter and participate in this study must be:
- •of non –child bearing potential ( i.e. physiologically incapable of becoming
- •pregnant (tubal ligation, documented hysterectomy), including any female who
- •is post-menopausal [> 1 year without menstrual period and FSH/estradiol
- •concentrations are consistent with postmenopausal state]. Other reasons for
- •amenorrhoea should also be excluded by the Investigator
- •5. Subject has given full written informed consent prior to any study-related procedures being performed.
- •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
- •1. Metabolic Disease including:
- •Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG >126mg/dL(>7.0mmol/L)
- •Uncorrected thyroid dysfunction
- •Significant weight gain or loss within the past 3 months prior to Screening Visit 2.
- •2. History of recent clinically significant cardiovascular disease at Visit 2 including:
- •CHD, CHF (NYHA Class II-IV), stroke, peripheral vascular disease.
- •History or ECG evidence of prior myocardial infarction in the past 6 months.
- •Current unstable angina or history of unstable angina in the past 6 months.
- •Coronary revascularization including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery
- •Clinically significant arrhythmia or valve heart disease.
- •Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm.
- •Has a QTc interval > 450 msec in males or females, QTcb or QTcf, machine or
- •manual overreads at Screening Visit 2.
- •Clinically significant ECG abnormalities
- •3. History of significant co-morbid diseases [e.g., severe Chronic Obstructive
- •Pulmonary disease (COPD), chronic gastrointestinal disease, etc.]
- •4. TGs in excess of 400mg/dL (4.52 mmol/L) at Visits 1 or 2 (for permitted re-test
- •details see Section 3.1.3)
- •5. Subjects with cTnI > 0.35ng/ml
- •6. Serum creatinine at Visit 2 > 1.4 mg/dL (124µmol/L) for females, or > 1.5mg/dL
- •(133µmol/L) for males at Visit 2.
- •7. Clinically significant anaemia defined by haemoglobin concentration (<12.0g/dL or
- •120.0 g/L) for males or (<11.0g/dL or <110.0g/L) for females at Visit 2
- •8. Documented history of hepato-biliary disease including a history of, or positive
- •laboratory results for hepatitis at Screening Visit 2, and/or clinically significant hepatic enzyme elevation, including any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:ALT, AST, ALP, total or direct bilirubin > 1.5 x ULN at Screening, unless consistent with presumed or diagnosed Gilbert’s disease.
- •9. History of metabolic acidosis or rhabdomyolysis, or a history of myalgia, myositis or
- •myopathy after taking statins and/or fibrates.
- •10. Signs or symptoms of myositis and/or CPK =3xULN at Visit 2
- •11. Any subject who has been withdrawn from therapy due to AEs after taking a PPAR? or a PPARa/? dual agonist
- •12. Any subject who is taking medications that are contraindicated for use in the
- •atorvastatin and simvastatin label.
- •13. Any subject currently taking or who has taken any of the following medications as
- •assessed at Screening Visit 2.
- •Lipid-lowering agents (with exception of simvastatin 20, 40 or 80 mg and
- •atorvastatin 10, 20, 40, or 80 mg) and drugs known to have substantial effect on
- •lipid metabolism including but not limited to fish oil and vitamins within 8 Weeks prior to pre-screening Visit 1
- •All oral glucose-lowering agents and insulin
- •Anti-obesity agents
- •Warfarin and digoxin
- •Oral or injectable corticosteroids
- •Oral anti-coagulant (other than aspirin, clopidogrel and non-steroidal anti-inflammatory drugs [NSAIDs]) within 30 days prior to the pre-screening Visit 1
- •Antiretroviral drugs
- •St. John’s Wort
- •Use of Thiazolidinedione ( TZDs )
- •Any major change in diet, exercise habits or smoking status
- •Methotrexate, cyclosporine or monoclonal antibodies for rheumatoid arthritis or psoriasis
- •Atypical antipsychotics medications
- •Monoamine oxidase inhibitors
- •Any OTC or herbal medications, including but not limited to vitamins supplements, unless prepared to cease self-me
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