None listed
Conditions
Interventions
This group will be treated with Simvastatin Placebo QD PO + TAK-475 Placebo QD PO. This regimen will continue for 12 weeks
Group name:ARM O Type of group
This group will be treated with Simvastatin 80 mg QD PO + TAK-475 100 mg QD PO. This regimen will continue for 12 weeks.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient corresponds to a male or female subject with at least 18 years of age. 2. Women of childbearing age should not be pregnant, determined by a negative control of serum HCG, should not be breastfeeding or planning to become pregnant between the time of selection and 30 days after the last dose of the study drug , and they must agree to use forms of contraception during the study. 3. Prior to Randomization, the patient should have an average LDL-C of ≥ 130 mg / dL (3.37 mmol / L) and ≤ 220 mg / dL (5.70 mmol / L) for 2 consecutive samples. The difference between the two individual values ​​of LDL-C must not exceed 15% of the highest value. 4. Prior to Randomization, the patient should have an average triglyceride value of ≤ 400 mg / dL (4.52 mmol / L) for 2 consecutive samples. The upper value of any of the TG samples should be ≤ 450 mg / dL (5.09 mmol / L). 5. The patient must have clinical laboratory evaluations within the reference range for laboratory control, unless the results are considered clinically insignificant or within the normal limits for this patient. 6. The patient has the will and capacity to continue with the compliance of a standardized diet low in cholesterol.
Exclusion criteria
Exclusion criteria: 1. The patient has a level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of> 1.5 times ULN, hepatic-active disease or jaundice. 2. The patient has a serum creatinine> 1.5 mg / dL (133 pmol / L). 3. The patient has a creatine phosphokinase (CPK)> 3 times ULN. 4. The patient has diabetes mellitus type 1 or 2. 5. The patient has a prior history of cancer that has been in remission for less than 5 years before the first dose of study medication. 6. The patient suffers from an endocrine disorder, which affects lipid metabolism. Patients with hypothyroidism who undergo adequate replacement therapy will be eligible for inclusion in the study. 7. The patient has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple factors that confer a risk of CHD at 10 years> 20% on the basis of Framingham risk score. 8. The patient has a positive control of the presence of surface antigen for hepatitis B or antibody to hepatitis C virus. 9. The patient has tested positive for human immunodeficiency virus or is taking antiretroviral medications. 10. The patient is unable or unwilling to discontinue the excluded medications or continue with stable doses of stable dose medications, or require treatment during the study with any medication excluded. 11. The patient has been exposed to TAK-475 in other studies or is currently participating in another research study or has participated in a research study within the past 30 days or, for drugs with a long half-life, within a period of less than 5 times the half-life of the drug. 12. The patient suffers from known hypersensitivity or a history of adverse reaction to simvastatin. 13. The patient has a history or presence of clinically significant allergy to foods that could prevent compliance with the TLC diet. 14. The patient suffers from a familiar heterozygous or homozygous familial hypercholesterolemia, or a known Type III hyperlipoproteinemia. 15. The patient has fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain. 16. The patient has uncontrolled hypertension. 17. The patient has inflammatory bowel disease or some other malabsorption syndrome, or has undergone gastric bypass or some other surgical procedure to lose weight. 18. The patient does not want or is unable to comply with the protocol or scheduled appointments. 19. The patient is unable to understand the spoken or written English language, or any other language for which a certified translation of the approved informed consent is available. 20. The patient has a history of drug use or a history of alcohol consumption within the last 2 years. 21. The patient suffers from any other disease or serious condition that could reduce life expectancy, impair successful management of the study or make the patient an unsuitable candidate to receive the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood samples for LDL-C with 10 hours of previous fasting. Measure:Percentage change with respect to Basal value in LDL-C in Week 12 or at the last visit under treatment. Timepoints:Before starting the study, day 1 and in weeks 2, 4, 8 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood samples for LDL-C, HDL-C, total cholesterol, triglycerides, Apo B, Apo A1, VLDL-C with 10 hours of previous fasting. Measure:Percentage change with respect to the baseline value for LDL-C, HDL-C, total cholesterol, triglycerides, Apo B, Apo A1 and VLDL-C by study visit. Proportion of patients reaching LDL-C concentrations of <160. <130 and <100 mg / dL. Timepoints:Before starting the study, day 1 and in weeks 2, 4, 8 and 12. ; Outcome name:Adverse events: Clinical evaluation in which a coding of adverse events will be done will be done using the latest available version of the Medical Dictionary for regulatory activities (MedDRA). Laboratory tests: Hematology panel, Serum biochemistry panel, Liver panel, urine test and hs-CRP. Other additional safety variables: Physical examination, vital signs, body weight, 12-lead ECG. Measure:Safety of treatment: Adverse Events. Laboratory exams. Other additional security variables. Timepoints:Adverse events: Weeks 2, 4, 8 and 12. Laboratory tests, vital signs, body weight: Before the study, day 1 and in weeks 2, 4, 8 and 12. hs-CRP, physical examination, 12-lead ECG: before starting the study, day 1 and week 12. | — |
Countries
Canada, Peru, United States
Outcome results
None listed