None listed
Conditions
Interventions
Group 1 Type of group
placebo PO for 8 weeks.
Group name:Group 4 Type of group
200 mg micronized PO phenofibrate once a day for 8 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men and women (either postmenopausal or, in case of being premenopausal, surgically sterilized or using the contraceptive pill or having an IUD placed for more than 3 months). Postmenopausal means the absence of menstruation during the previous 18 months. If the cessation of menstruation is within 3 years, FSH should be elevated to the post-menopausal range in Visit 1, Day -28. All premenopausal women should have a negative 6-hCG test at Visit 3, Day 1. • Age between 21 and 65 years old. • Mixed hyperlipidemia defined as Total-C of> 190 mg / dL (4.81 mmol / L) (as an average of Visit 1, Day -28 and Visit 2, Day -7) and apo-B> 115 mg / dL in Visit 2, Day -7 and average TG of 250 to 700 mg / dL (from 2.82 to 7.90 mmol / L) of Visit 1, Day -28 and Visit 2, Day -7. • Liver transaminase values ​​(ALT or SGPT and AST or SGOT) <20% above ULN (ALT <30 mg / dL and AST <27 mg / dL) and CK <50% ULN (<180 mg / dL) at Visit 2, Day -7 unless there is an obvious aetiology for elevation. • Consumption of alcohol <7 drinks per week
Exclusion criteria
Exclusion criteria: • A diagnosis of type I, IV and V dyslipidemia or homozygous familial hypercholesterolemia. • Hypercholesterolemia secondary to hypothyroidism [TSH> 10 pUI / mL, measured at Visit 1, Day -28 and Total T4 10 pUI / mL]. Patients with a history of hypothyroidism, which are in a stable dose of thyroxine with plasma thyroxine and normalized TSH, may be included. • Secondary dyslipidemia due to nephrotic syndrome or HIV. • Previous use of lipid alteration agents taken for 4 weeks, including agents that produce bile acid sequestration, HMG-CoA reductase inhibitors and nicotinic acid; or fibrates taken for 6 weeks; or probucol in a 1 year, prior to Visit 2, Day -7 • Documented coronary disease (ie, acute coronary syndrome, including unstable angina, Q-wave and Q-wave myocardial infarction, previous percutaneous transluminal coronary angioplasty or coronary bypass surgery) and patients with Class 2 cardiac status, 3 and 4 of the New York Heart Association (NYHA) and / or history of clinically significant peripheral edema in the past 6 months. • Uncontrolled hypertension (treated or untreated) with systolic blood pressure typically> 160 mm Hg or diastolic> 95 mm Hg. • Patients taking or using 1 or more of the following: warfarin or warfarin-type anticoagulants, digoxin, theophylline, anti-dysrhythmic or anticonvulsant medications; cyclosporin; itraconazole and systemic ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil and inhibitors of HIV proteases; St. John´s malt, grapefruit or grapefruit juice. • Known hypersensitivity to fenofibrates, gemfibrozil, bezafibrate, troglitazone, pioglitazone or rosiglitazone. • Renal impairment as measured by serum creatinine> 1.5 mg / dL (132.6 mmol / L). • Active liver disease, including hepatitis A, B or C (as determined by positive IgM for Type A, positive for central antigen in Type B and positive for Type C antibodies) or biliary cirrhosis. • History of pancreatitis. • History of gallbladder disease including cholelithiasis. • Patients with known diabetes mellitus Type 1 or 2 as confirmed by fasting plasma glucose> 140 mg / dL (7.8 mmol / L) or a treatment with antidiabetic medication. • Partial ileal shunt. • Patients whose weight is> 280 pounds or 50% below the ideal weight, according to the 1983 Metropolitan Height and Weight Insurance Tables • Compliance with dose taking during the transition phase with placebo <75%. • Surgery and / or treatment with any other investigational drug within 30 days prior to Visit 2, Day -7. • History of anemia (defined as hemoglobin <10 g / dL) that requires specific treatment within 5 years of Visit 1 or a history of thrombocytopenia (defined as platelet count less than 100,000 / pL) within 5 years of Visit 1 • Patient with a history of neoplastic disease with the exception of: patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix. No exception will be applied. • Any other condition or therapy that, in the opinion of the investigator, could represent a risk to the patient or confuse the results of the study. • Bad mental function or any other reason to suppose some difficulty of the patient in fulfilling the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Lipidic profile Measure:Total triglycerides Timepoints:Week 4, 6, 8 and 12 of having started the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events are recorded in the Adverse Event Case Report Forms. Measure:Safety Timepoints:During the duration of the study ; Outcome name:Lipidic profile Measure:TG-VLDL; Total-C, NON-HDL-C, LDL-C, VLDL-C, HDL-C Timepoints:Week 8 ; Outcome name:Biochemical profile with fasting plasma glucose, Insulin and fasting c-peptide Measure:Fasting plasma glucose and insulin, c-peptide, and HbA1c Timepoints:Weeks 2, 4, 6, 8 y 10 ; Outcome name:Serum test of CRP, inhibitor of plasminogen activator-1 (PAI-1) and fibrinogen. Measure:CRP, plasminogen activator inhibitor-1 (PAI-1) and fibrinogen Timepoints:Week 4 and 8 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed