Primary Hypercholesterolaemia, Mixed Hyperlipidaemia
Conditions
Brief summary
A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.
Interventions
Duration of Treatment - 24 weeks
DRUGER-niacin
Duration of Treatment - 24 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD). * Have medical conditions considered to be CHD equivalent). * LDL-C below 130 mg/dL for patients with multiple risk factors. * LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides \</= to 350 mg/dL.
Exclusion criteria
* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients \< 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications. * Pregnant or lactating women, or women intending to become pregnant are excluded. * Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). * Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reductions of LDL-C concentrations at 24 weeks and better tolerability | at 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Elevations in HDL-C concentrations at 24 weeks | at 24 weeks |
Outcome results
None listed