None listed
Conditions
Interventions
Group 1 Type of group
Simvastatin (Zocor®) 10 mg and a placebo of F-I394 daily for 8 weeks
Group name:Group 4 Type of group
Simvastatin (Zocor®) 10 mg and F-1394 100 mg PO daily for 8 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men and women (postmenopause). Postmenopause is defined as the absence of menstruation during the previous 18 months. If cessation of menstruation is within the last 3 years, FSH should be raised in the postmenopausal range at Visit 1, Day-28. • Age from 21 to 65 years old. • Primary hyperlipidemia defined as 100 mg / dL <Total C <300 mg / dL (or 2.58 to 7.75 mmol / L) and TG <400 mg / dL average (4.51 mmol / 1) (averaged at Visit 1, Day -28 and Visit 2, Day -7) while being treated with simvastatin 10 mg / day for a minimum period of 4 weeks or ready for a lipid alteration treatment. • Values ​​of hepatic transaminases (ALT or SOFT and AST or SGOT) <20% above upper limit of normal (ULN) (ALT <30 mg / dL and AST <27 mg / dL), and CK <50% above of LSN (<180 mg / dL) at Visit 2, Day -7 unless there is an obvious aetiology for elevation. • Alcohol consumption of <4 drinks per day or <14 drinks per week in total.
Exclusion criteria
Exclusion criteria: • Diagnosis of type I, IV and V dyslipidemia or homozygous familial hypercholesterolemia. • Hypercholesterolemia secondary to hypothyroidism [TSH> 100 uIU / mL, measured at Visit 1, Day -28 and total T4 10 p.lU/ mL]. Patients with a history of hypothyroidism, who are given a stable dose of thyroxine with TSH and normalized plasma thyroxine, may be included. • Dyslipidemia secondary to nephrotic syndrome or HIV. • Use of lipid-altering agents in the 2 weeks prior to Visit 1, Day -28, including bile acid and nicotinic acid sequestrants; or fibrates taken in the last 4 weeks; or probucol in the last year, before Visit 2, Day -7. If a patient is currently treated with a HMG-CoA reductase inhibitor including dose of> 40 mg / day of simvastatin, dose> 40 mg / day of atorvastatin or 80 mg / day of lovastatin and pravastatin, he should be excluded from the study. • Documented coronary artery disease (ie, acute coronary syndrome, including unstable angina, Q-wave myocardial infarction or non-Q wave, previous percutaneous transluminal coronary angioplasty, or coronary bypass surgery) or cerebrovascular disease (ie, stroke) within the last 6 months. • Uncontrolled hypertension (treated or untreated) with systolic blood pressure typical of> 160 mm Hg or diastolic> 95 mm Hg. • Patients taking or using one or more of the following: warfarin anticoagulants or warfarin-like, digoxin, theophylline, anti-dysrhythmic or anticonvulsant medications; cyclosporin; systemic itraconazole and ketoconazole, erythromycin or clarithromycin, nefazodone, mibefradil and HIV protease inhibitors; St. John´s wart, grapefruit or grapefruit juice, oral contraceptives. • Known hypersensitivity to a reductase inhibitor HMG-CoA or ACAT. • Renal insufficiency according to the serum creatinine measurement of> 1.5 mg / dL (132.6 mmol / L). • Active liver disease or biliary cirrhosis. • Patients with diabetes mellitus of type 1 or 2 according to the confirmed measurement of fasting plasma glucose of> 140 mg / dL (7.8 mmol / L) or a treatment with antidiabetic medication. • Partial deviation of the ileum. • Patients whose weight is greater than 280 pounds (127.8 kg). • Transitional compliance with placebo of <75% for each formulation. • Surgery and / or treatment with another investigational drug in the 30 days prior to Visit 2, Day -7. • Patients with a history of neoplastic disease with the exception of: patients with adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. • Any other condition or therapy that, in the opinion of the investigator, could put the patient at risk or confuse the results of the study. • Poor mental function or any other reason that could cause the patient to have difficulty meeting the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The following parameters: total C, LDL-C, non-HDL-C, HDL-C, TG, VLDL cholesterol, VLDL triglycerides, apolipoprotein B and A-I; CRP, plasminogen activator 1 (PAI-1), homocysteine and fibrinogen. Measure:Efficacy Timepoints:Fasting blood samples will be taken (at least 12 hours after the last meal) on Days -28, -7, 1, 14 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Record of adverse events Measure:Safety Timepoints:During the duration of the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed