Familial Combined Hyperlipidaemia Nutritional, Metabolic, Endocrine Hyperlipidaemia
Conditions
Interventions
Sponsors
Takeda Europe R and D Centre (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Whole body glucose uptake 2. Myocardial glucose uptake 3. Basal myocardial blood flow 4. Coronary vasodilator reserve | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters of lipid and carbohydrate metabolism. | — |
Countries
United Kingdom
Outcome results
None listed