Atherosclerosis, Hypercholesterolaemia
Conditions
Brief summary
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
Interventions
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
DRUGSimvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Sponsors
Merck Sharp & Dohme LLC
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* \>=18 years and \<= 75 years of age * LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) at baseline. * Triglyceride concentration \<3.99 mmol/L (350 mg/dL) at baseline. * Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI. * Stable weight history for at least 4 weeks prior to entry into study at baseline. * Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
Exclusion criteria
* Body mass index (BMI) \>=35 kg/m\^2 at baseline. * Subjects whose liver transaminases (ALT, AST) are \>1.5 times the upper limit of normal and with active liver diseases at baseline. * Subjects with evidence of current myopathy (including subjects with CK\>1.5 times above the upper limit of normal) at baseline. * Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline. * Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c\>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline. * Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control. * Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors. * Female subjects who consume \>14 units and male subjects who consume \>21 units of alcohol per week. * Female subjects who are pregnant or breast feeding. * Subjects who have not observed the designated washout periods for any of the prohibited medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline to endpoint. | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. | 6 weeks |
| Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. | 6 weeks |
| Safety: adverse events, laboratory test results, vital signs. | Throughout study |
Outcome results
None listed