Primary hypercholesterolemia
Conditions
Interventions
Product Name: MK 6213
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Tablet
Route of administr
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female and 18 to 75 years of age on day of signing informed consent. 2. Patient is (a) female and not of reproductive potential or postmenopausal, or (b) female of reproductive potential who agrees to take acceptable contraceptive precautions for the duration of the study. 3. Patient is classified as “low risk” (0-1 risk factors) according to NCEP/ATPIII cardiovascular risk categories and Framingham risk score with an off-treatment LDL-C value of 100-190 mg/dL (2.6–4.9 mmol/L) -or- 4. Patient is classified as “moderate risk” (2 or more risk factors and 10 year CHD risk=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has a history of coronary heart disease, congestive heart failure Class III or IV, renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease. Patient has a history of mental instability or drug/alcohol abuse within the past 5 years. Patient drinks more than 2 alcoholic drinks per day. Patient is pregnant or nursing. Patient is HIV positive. Patient has a history of cancer within the past 5 years. Patient has been in a investigational trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MK-6213 160 mg co-administered with atorvastatin 20 mg compared to atorvastatin 20 mg as monotherapy in lowering LDL-C in patients with primary hypercholesterolemia treated for 4 weeks. ;Secondary Objective: 1) To evaluate the safety and tolerability of MK-6213 160 mg treatment 2) To evaluate the efficacy of MK-6213 160 mg monotherapy compared to placebo in lowering LDL-C, non-HDL-C, Apo B, TC and TG and rising HDL-C 3) To evaluate the efficacy of MK-6213 160 mg co-administered with atorvastatin 20 mg compared to atorvastatin 20 mg monotherapy in lowering non-HDL-C, Apo-B, TC and TG and rising HDL-C;Primary end point(s): Reduction in LDL-C | — |
Countries
Finland, Germany, Sweden
Outcome results
None listed