None listed
Conditions
Interventions
Group 1 Type of group
Anacetrapib of 100 mg. The patient will be instructed to take 1 tablet daily with a meal.
Group name:Group 2 Type of group
100 mg placebo The patient will be instructed to take 1 tablet daily with a meal.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • The patient is a man or a woman who is> 18 and <80 years old on the day of the signing of the informed consent. • Based on the NCEP ATP III guidelines, the patient has CHD / disease with an equivalent risk of CHD (including diabetes) and LDL-C <100 mg / dL (2.59 mmol / L). • The patient is treated with a statin ± another lipid modifying therapy and has HDL-C <60 mg / dL (1.55 mmol / L). • The patient has triglyceride concentrations (TG) <400 mg / dL (4.52 mmol / L). • A patient who is potentially fertile agrees to remain in abstinence * or use (or have her partner use) 2 acceptable methods of birth control throughout the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy and hormonal contraceptive. • The patient has a study drug compliance greater than 75% during the transition phase with single blind placebo (as determined by pill count) or, according to the opinion of the researcher, compliance will improve after counseling additional.
Exclusion criteria
Exclusion criteria: • The patient has severe chronic heart failure defined by Classes III or IV established by the New York Heart Association (NYHA). • The patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke, MI within 3 months prior to Visit I. • LDL-C 2 x upper limit of normal (ULN) [according to the central laboratory reference ranges]. ALT (alanine aminotransferase), or AST (aspartate aminotransferase)> 2 x upper limit of normal (ULN) [according to the reference ranges of the central laboratory]. • The patient has recently diagnosed Type 1 or Type 2 diabetes (within 3 months of Visit 1) or poorly controlled (HbAlc> 8.5%). Note: Patients who are currently receiving antidiabetic drug (s) should be in a stable dose regimen (except for ± 10 units of insulin) for a minimum of 3 months before Visit 1. • A patient has hyper or hypothyroidism that is defined by a TSH below the reference range of the lower limit of the normal central laboratory or> 20% above the reference range of the upper limit of normal. Note: In the case of patients receiving a thyroid hormone, there is no lower threshold of TSH for admission and the patient must be at a stable dose for> 6 weeks before the randomization visit. Note: A review will be carried out if the original value of the TSH is less than 40% above or below the reference range, but the patient must meet the criteria after the review. • The patient has homozygous familial hypercholesterolemia, Type I or V hyperlipidemia. • The patient has an active or chronic hepatobiliary or hepatic disease. • The patient has an eGFR 300 mL within 8 weeks of signing the informed consent, or intends to donate 250 mL of blood products or receive blood products within the projected durat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of lipid profile values throughout the study. Measure:Percentage change from baseline in LDLC in Week 24. Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of lipid profile values throughout the study. Measure:Percentage change with respect to baseline in the HDL-C in Week 24 and 76 Timepoints:Week 24 and Week 76 ; Outcome name:Measurement of lipid profile values throughout the study. Measure:Percentage change from baseline in No HDL-C in Week 24 and 76 Timepoints:Week 24 and 76 ; Outcome name:Measurement of lipid profile values throughout the study. Measure:Percent change from baseline in Apo B in Week 24 and 76 Timepoints:Week 24 and 76 ; Outcome name:Measurement of lipid profile values throughout the study. Measure:Percent change from baseline in Apo-A1 in Week 24 and 76 Timepoints:Week 24 and 76 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed