Hypercholesterolemia
Conditions
Brief summary
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
Interventions
DRUGezetimibe
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
DRUGsimvastatin
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Matching ezetimibe placebo
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit * Age of at least 18 years and 75 years or less * Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l
Exclusion criteria
* Congestive heart failure (defined as New York Heart Association class III or IV heart failure) * Uncontrolled cardiac arrhythmias * Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry * History of unstable or severe peripheral artery disease within 3 months of study entry * Uncontrolled hypertension at study entry * Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry) * Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function * Active or chronic hepatic and hepatobiliary disease * Disorders that would limit study evaluation or participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction of LDL-C after 6 weeks of treatment. | 6 weeks |
Outcome results
None listed