ISRCTN78563659已完成不适用
A study to investigate the effect of pioglitazone on whole body and myocardial glucose uptake and myocardial blood flow/coronary vasodilator reserve in patients with familial combined hyperlipidaemia
Takeda Europe R and D Centre (UK)0 个研究点目标入组 26 人开始时间: 2005年10月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients must be/have:
- •1. Male or female aged between 30 and 70 years
- •2. Familial Combined Hyperlipidaemia (CHL) that fits the diagnostic criteria
- •3. Inadequately controlled with conventional lipid lowering medication, with at least one of
- •the following:
- •3.1. Total cholesterol more than 5.0 mmol/l
- •3.2. Triglyceride more than 1.7 mmol/l
- •3.3. High Density Lipoprotein (HDL) cholesterol less than 1.0 mmol/l
- •3.4. Total cholesterol: HDL-cholesterol ratio more than 5.0
- •4. On stable lipid lowering medication (dose and drug) for the previous two months
- •5. A Body Mass Index (BMI) of less than or equal to 35 kg/m^2
- •6. Willing and able to comply with the conditions and requirements of the study
- •7. Signed and dated an informed consent form and be able to comply with the study procedures
排除标准
- •Patients must not be/have:
- •1. Had a myocardial infarction, stroke or transient ischaemic attack in the previous six months
- •2. Had malignant disease in the previous five years (except basal cell carcinoma)
- •3. Undergoing haemodialysis
- •4. Any of the following conditions:
- •4.1. Type one or type two diabetes mellitus
- •4.2. Chronic uncontrolled asthma
- •4.3. An inability to tolerate PET scanning
- •4.4. New York Heart Association (NYHA) class II, III or IV congestive heart failure
- •4.5. Alcohol or drug abuse
- •4.6. Significant renal impairment (defined as creatinine more than 135 µmol/l)
- •4.7. Abnormal liver tests (defined as alanine aminotransferase [ALT] more than 2.5 times the upper limit of the reference range)
- •4.8. Known Human Immunodeficiency Virus (HIV) infection or viral hepatitis
- •5. Had treatment with corticosteroids in the previous four weeks (use of topical or inhaled corticosteroids is allowed)
- •6. Taken another investigational study drug or product within the previous three months
- •7. Donated and/or received any blood or blood products within the previous three months
- •8. Female patients who are any of the following:
- •8.1. Pregnant, planning pregnancy during the study or breast feeding
- •8.2. Of child-bearing potential and not planning to use a reliable method of contraception throughout the study (e.g. intrauterine device [IUD] or oral contraception)
- •9. Any other condition or circumstance that in the opinion of the investigator may compromise the patient?s ability to comply with the study protocol
研究者
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