EUCTR2005-001558-26-ES进行中（未招募）1 期
A RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTRE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF ORAL GW677954 CAPSULES 2.5mg, 5mg, 10mg AND 20mg A DAY FOR WEEKS IN OVERWEIGHT DYSLIPIDAEMIC SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Waist circumference =102cm (men) or =88cm (women) at visit 1
- •2. Fasting plasma HDL-C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L)
- •(women) at Screening Visit 1
- •3. Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening
- •4. Subjects whose plasma LDL-C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1
- •Plasma LDL-C concentration =190mg/dL (=4.91mmol/L) if no more than one
- •cardiovascular risk factor, or
- •Plasma LDL-C concentration =160mg/dL (=4.13mmol/L) if two or more
- •cardiovascular risk factors, and a 10-year congestive heart failure (CHF) risk
- •=10% (Framingham Point Scores), or
- •Plasma LDL-C concentration =130mg/dL (=3.36mmol/L) if two or more
- •cardiovascular risk factors, and a 10-year CHF risk >10% and =20%
- •(Framingham Point Scores).
- •5. Male and female subjects 18 to 70 years of age (inclusive at the time of Screening) at Visit 2
- •6. Females, to be eligible to enter and participate in this study must be:
- •either, of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or, of child-bearing potential and have a negative pregnancy test at Screening (serum), and: have a male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject, or use double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intrauterine devices are acceptable, or use hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or abstain from sexual intercourse, or be with a same sex partner and does not participate in bisexual activities where there
- •is any risk of pregnancy.
- •7. Subject has given full written informed consent prior to any study-related procedures are performed.
- •8. If subject is a smoker, must be able to abstain while in clinic at each visit.
- •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 at Screening, and at Visit 2 both >126mg/dL (>7.0mmol/L);
- •Uncorrected thyroid dysfunction;
- •Significant weight gain or loss within the 3 months prior to Screening (Visit 1).
- •2. History of recent clinically significant cardiovascular disease at Visit 2 including:
- •History or ECG evidence of prior myocardial infarction
- •Current unstable angina or history of unstable angina
- •Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
- •Clinically significant arrhythmia or valvular heart disease.
- •Congestive heart failure with NYHA Class II-IV symptoms.
- •Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm at Visit 2.
- •Has a QTc interval > 440 msec in males and > 450 msec in females at Visit 2
- •Clinically significant ECG abnormalities
- •3. History of chronic pancreatitis;
- •4. Diagnosis of either Familial hypercholesterolaemia or Familial combined hyperlipidaemia
- •5. History of TGs in excess of 800mg/dL (8.96mmol/L)
- •6. Serum creatinine at visit 2 > 1.4 mg/dL (124µmol/L) for women, or > 1.5mg/dL
- •(133µmol/L) for men at visit 2.
- •7. Clinically significant anaemia defined by haemoglobin concentration <12.0g/dL or
- •<120.0g/L for males and <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 (hepatitis B surface antigen, hepatitis B core antigen,
- •and/or hepatitis C antibody) at Run-in [Visit 2], and/or clinically significant hepatic
- •enzyme elevation including:
- •Any one of the following enzymes greater than 2.5 times the ULN value:
- •- Alanine aminotransferase
- •- Aspartate aminotransferase
- •- Alkaline phosphatase
- •Total or direct bilirubin >1.5 x ULN, unless due to diagnosed or presumed 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 CK >3 x ULN at Screening;
- •11. Is currently taking or has taken any of the following medications in the 3 months
- •prior to Screening (Visit 1) as assessed at visit 2:
- •All lipid-lowering agents and drugs known to have substantial effect on lipid
- •All oral glucose-lowering agents and insulin
- •Anti-obesity agents
- •Warfarin and digoxin
- •Oral or injectable corticosteroids (other than inhaled, intranasal and topical)
- •Oral anti-coagulant (other than aspirin, clopidogrel and non-steroidal
- •anti-inflammatory drugs [NSAIDs])
- •Antiretroviral drugs
- •St. John’s Wort
- •Use of TZDs in the 3 months prior to the screening
- •Methotrexate, cyclosporine or monoclonal antibodies
- •Atypical antipsychotics medications
- •Monoamine oxidase inhibitors
- •12. History of cancer
- •13. Women who are lactating, pregnant, or planning to become pregnant.
- •14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug
- 另有 6 项未显示
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