Primary Hypercholesterolaemia
Conditions
Interventions
Trade Name: Inegy
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Merck & Co Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female and aged over 18 2. Patient provides written informed consent 3. Patient has a fasting LDL-C level ?2mmol/l at both visit 1 and again at visit 2 4. Patient has established CVD, diabetes or at “high risk” of CVD (>20 % risk over 10 years, Framingham scale) 5. Patient has taken simvastatin 40mg continuously for the past 6 weeks 6. Patient has a fasting triglyceride level of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is hypersensitive to any of the study medications or their components 2. Patient has a history of, or active liver disease (persistent elevation of ALT / AST (>3xULN) 3. Patient is pregnant, lactating, or a female patient of childbearing potential not using adequate contraception 4. Patient has severe renal impairment: creatinine clearance 10 x ULN at visit 1 or visit 2 8. Patient has fasting LDL-C >4.2mmol/l 9. Patient has any acute or serious condition, or history suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, severe endocrine and electrolyte disorders or uncontrolled seizures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the percentage of patients with either established CVD, at “high risk” of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C ?2mmol/l, who are able to attain the recommended LDL-C target of <2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.; Secondary Objective: In this same patient population to determine the: 1. Percentage reduction in fasting LDL-C from baseline 2. Percentage of patients who achieve a total cholesterol value of <4mmol/l 3. Percentage reduction in total cholesterol from baseline 4. Percentage reduction in triglycerides from baseline 5. Safety and tolerability of ezetimibe/simvastatin 10/40mg, atorvastatin 40mg and rosuvastatin 10mg ;Primary end point(s): The primary endpoint is the proportion of patients achieving a target of <2mmol/l fasting LDL-C following 6 weeks treatment. Statistical significance of the difference between the ezetimibe/simvastatin 10/40mg group and each of the comparator groups (atorvastatin 40mg and rosuvastatin 10mg) will be assessed from a logistic regression analysis. Factors in the logistic regression model will be treatment and stratum. The secondary endpoint of the proportion of patients achieving the total cholesterol target of <4mmol/l will be analysed using a similar model. | — |
Countries
United Kingdom
Outcome results
None listed