Hypercholesterolemia
Conditions
Brief summary
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
Interventions
DRUGMK0733, simvastatin / Duration of Treatment: 12 Weeks
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient, \>18 years of age * Patients with hypercholesterolemia who meet the following lipid criteria: 1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl 2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl * The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study
Exclusion criteria
* Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris * Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1 * Uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1. * Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks | — |
Countries
Taiwan
Outcome results
None listed