None listed
Conditions
Interventions
Group 1 Type of group
10/20 mg of ezetimibe / simvastatin and 160 mg of fenofibrate for 12 weeks
Group name:Group 4 Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is 18 to 79 years of age. • The patient is a post-menopausal man or woman. The patient is a pre-menopausal woman who is surgically sterile or who is highly unlikely to conceive, and who has a negative pregnancy test at Visit 1. • The patient will follow a stable diet throughout the study. • The patient maintains a stable weight (± 2 kg) for> 6 weeks before Visit 1. • The patient has a LDL-C level of 130 to 220 mg / dL (3.37 to 5.70 mmol / L) if he / she does not have diabetes; LDL-C from 100 to 180 mg / dL (2.59 to 4.66 mmol / L) if you have diabetes. • The patient has a triglyceride level of 150 to 500 mg / dL (1.71 to 5.70 mmol / L). [according to the reference ranges of the central laboratory] in Visit 2. • The patient has a creatine phosphokinase (CPK) level <2 x the upper limit of normal (ULN) [according to the reference ranges of the central laboratory] in Visit 2. • The patient has a level of alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <1.5 x the upper limit of normal (ULN) [according to the reference ranges of the central laboratory] in Visit 2.
Exclusion criteria
Exclusion criteria: • The patient has Chronic Class II or IV heart failure as defined by the New York Heart Association (NYHA). • The patient has uncontrolled cardiac arrhythmias. • The patient has a history of coronary heart disease (CHD), a disease equivalent to CHD, with the exception of diabetes mellitus, [for example, peripheral arterial disease (femoral, popliteal), abdominal aortic aneurysm, symptomatic carotid artery disease (TIA), stroke)] or risk of CHD> 20%, as indicated by the National Cholesterol Education Program (NCEP) ATP criteria (Appendix 4 and 5). • The patient has unstable hypertension (systolic blood pressure> 160 mm Hg or diastolic blood pressure> 100 mm Hg) at Visit 1. • The patient suffers from hematological, digestive or central nervous system disorders, including a degenerative disease that limits the evaluation or participation in the study. • The patient has inadequately controlled diabetes mellitus (HbAlc> 8.5%), or has recently been diagnosed (within 3 months), or has had a recent change in antidiabetic pharmacotherapy (ie, a change in dosage [a exception of ± 10 units of insulin] or the addition of a new medication) within 3 months of Visit 1. • The patient suffers from an uncontrolled endocrine or metabolic disease that is known to influence serum lipids or lipoproteins (ie, secondary causes of hyperlipidemia). • The patient suffers from homozygous familial hypercholesterolemia, type I or V hyperlipidemia, or receives an LDL apheresis treatment. • The patient has a history of cholelithiasis and has not undergone cholecystectomy. • The patient has an active or chronic hepatobiliary or hepatic disease. • The patient has a serum creatinine level> 1.5mg / dL (133 micromol / L) at Visit 1, nephrotic syndrome, or other clinically significant kidney disease. • The patient has a serum creatinine level of 1.1 to 1.5 mg / dL (97 to 133 micromol / L), and their creatinine clearance (calculated using the Cockroft-Gault formula, Appendix 3) is 6 weeks prior to randomization (Visit 3). • The patient has been receiving treatment with orlistat, sibutramine, or another anti-obesity m
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of Total C, TG, no HDL-C, HDL-C, VXDL-C, VLDL-TG, Apo B, and Apo A-I. Measure:Changes in levels of Total C, TG, not HDL-C, HDL-C, VXDL-C, VLDL-TG, Apo B, and Apo A-I. Timepoints:12 weeks ; Outcome name:Measurement of Apo C-IQ, Apo C-IHiB, Apo C-III: no B, LDL-Apo B, RLP-C, fibrinogen, CRP and subclasses of LDL. Measure:Change in the levels of Apo C-IQ, Apo C-IHiB, Apo C-III: no B, LDL-Apo B, RLP-C, fibrinogen, CRP and subclasses of LDL. Timepoints:12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The endpoint value is defined as the last post-baseline measurement during the double-blind treatment period of 12 weeks, without taking into account whether the patient took the study drug during that period. Measure:Percentage change from the LDL-C baseline to the final point after 12 weeks of treatment Timepoints:12 weeks | — |
Countries
Australia, Austria, Bosnial and Herzegovina, Canada, Colombia, Costa Rica, France, Guatemala, Hungary, Israel, Mexico, Russian Federation, Spain, Taiwan, United Kindgdom
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed