Atherosclerosis, Hypercholesterolemia
Conditions
Brief summary
This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.
Interventions
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
DRUGAtorvastatin
oral tablets: atorvastatin 10 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
* Male and non-pregnant female subjects, who demonstrated willingness to participate and comply with procedures by signing informed consent, and who were \>=18 years and \<=75 years of age, were eligible to participate if they had: a baseline LDL-C concentration \>=3.3 mmol/L (130 mg/dL) to \<=4.9 mmol/L (190 mg/dL); a baseline triglyceride concentration of \<3.99 mmol/L (350 mg/dL); a documented history of coronary heart disease (CHD); a stable weight history for 4 weeks prior to baseline; completion of the designated washout periods for all prohibited medications; and did not fulfill any of the
Exclusion criteria
for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline to endpoint. | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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