None listed
Conditions
Interventions
Group 1 Type of group
Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Group name:Group 2 Type of group
Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female> 18 years of age and 115 mg / dL 2 risk factors with a 10-year risk in the Framingham Study 115 mg / dL 75 and <350 mg / dL.
Exclusion criteria
Exclusion criteria: • The patient is pregnant, breastfeeding or expects to conceive during the study including follow-up 14 days post-study. • The patient has a history of malignancy 300 mL within 8 weeks prior to signing the consent. Plan to provide or receive blood products during the study. He plans to donate more than 250 mL of blood products within 8 weeks after the last study visit. • The patient consumes more than 3 alcoholic beverages per day or more than 14 drinks per week. Please refer to Section 3.2.2.3 for the definition of alcoholic beverages. • The patient is currently experiencing hot flashes from menopause. • The patient presents the following exclusion laboratory values ​​at Visit 1. (Refer to Table 3-8 for the test repeat guidelines). • The patient presented 126 mg / dL. • Patients have chronic heart failure defined according to Class III or IV of the New York Association (NYHA). • The patient has poorly controlled cardiac arrhythmias. • The patient has a history of hemorrhagic stroke or any other major nontraumatic hemorrhage. • The patient has poorly controlled hypertension (treated or untreated) with systolic blood pressure> 160 mm Hg or dias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood samples (obtained at least 10 hours after the last meal / snack / drink other than water) will be obtained at all visits. The central laboratory will perform all lipid and lipoprotein determinations, laboratory tests related to glycemic control and laboratory tests related to the liver and muscles. Measure:Percent change from baseline in LDL-C and HDL-C on Day 29. Timepoints:Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood samples (obtained at least 10 hours after the last meal / snack / drink other than water) will be obtained at all visits. The central laboratory will perform all lipid and lipoprotein determinations, laboratory tests related to glycemic control and laboratory tests related to the liver and muscles. Measure:Percentage change from baseline on Day 29 in TG. Timepoints:Day 29 ; Outcome name:Fasting blood samples (obtained at least 10 hours after the last meal / snack / drink other than water) will be obtained at all visits. The central laboratory will perform all lipid and lipoprotein determinations, laboratory tests related to glycemic control and laboratory tests related to the liver and muscles. Measure:Change from baseline in fasting plasma glucose, fasting serum insulin and insulin resistance, as measured by HOMA-IR and MOMA 13 on Day 29 Timepoints:Day 29 | — |
Countries
Canada, Colombia, Finland, Malasya, Peru, Philippines, Sweden, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed