Dyslipidemia MedDRA version: 9.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Product Name: MK-1903
Product Code: MK-1903
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
Current Sponsor code: MK-1903
Other descriptive name: (4aR)-4,4a,5,5a-tetrahydro-1H-cyclopropa[4,5]cy
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient meets one of the following criteria per (NCEP ATP III guidelines): Low Risk: 0-1 risk factors with LDL-C = 115 mg/dL =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has CHD or CHD Risk Equivalent Diseases (high risk, according to the NCEP ATP III Categorization), including Type 1 or Type 2 diabetes mellitus. 2. Patients with screening fasting plasma glucose = 126 mg/dL. 3. Patient is currently taking or has taken lipid-modifying therapy including prescription products [e.g. statins, ezetimibe, niacin >50 mg, bile acid sequestrants, red yeast rice products (e.g., Cholestin™), prescription omega-3-acid ethyl esthers (e.g., Lovaza™)] within 6 weeks of Visit 1, or fibrates within 8 weeks of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the LDL-C lowering efficacy and HDL-C raising efficacy of MK-1903 relative to placebo.;Secondary Objective: To evaluate the efficacy, and safety and tolerability of MK-1903 relative to placebo on triglycerides.;Primary end point(s): Percent change from baseline in LDL-C, HDL-C at Day 29 | — |
Countries
Finland, Sweden
Outcome results
None listed