None listed
Conditions
Interventions
Group 1 Type of group
100 mg of TAK-475 (and atorvastatin placebo) once a day
Group name:Group 3 Type of group
100 mg of TAK475 and 10 mg of atorvastatin once a day
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Be men or women of> 18 years of age. • Having a history of dyslipidemia (fasting LDL-C levels> 160 mg / dL (4.15 mmol / 1) and triglycerides of 1 year due to menopause). • Have a good physical and mental health determined by a doctor according to medical history, physical examination and laboratory results • Have read and understood the Patient Information Sheet and signed the Informed Consent Form • They should have fasting LDL-C levels of> 130 mg / dl (3.37 mmoIA) <190 mg / dl (4.92 mmol / 1) and triglycerides of <400 mg / dl (4.52 mmol / L) • Have an assessment according to the lens opacity classification system (LOCS lE) of nuclear opalescence less than or equal to 3.0, cortical cataract less than or equal to 2.0, posterior subcapsular cataract less than or equal to 1.0, and nuclear color less than 3.0
Exclusion criteria
Exclusion criteria: • Presenting coronary heart disease or risk factors for coronary heart disease that include: Diabetes mellitus type I or E, history or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischemic attacks or stroke • Have a body mass index (BMI) of 35 kg / m2 • Having a background or presence of: o Drug abuse (defined as the use of illicit drugs) or a history of alcohol abuse (defined as the routine consumption of> 21 units of alcohol per week) within 2 years prior to prescreening o Presenting uncontrolled hypertension (stage 2 hypertension, defined as resting mean diastolic blood pressure of> 100 mm Hg or mean resting systolic blood pressure of> 160 mm Hg) o Presenting hyperthyroidism or uncontrolled hypothyroidism or being patients whose thyroid replacement therapy has begun within the last 3 months o Have a positive HIV status, liver disease, hepatitis B or C o Present a malignancy (tumor), except for patients whose malignancy has been diagnosed as a basal or squamous cell carcinoma of Stage 1 o Presenting heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia) o Present fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and / or discontinuation of HMG-CoA reductase inhibitor medications due to the presence of myalgia o Having suffered trauma or ocular radiation, glaucoma, iritis, uveitis, previous intraocular surgery, laser surgery for the iris, retinal photocoagulation or laser trabeculoplasty, corneal opacification or other media opacities, or having undergone LASIK refractive surgery within the 6 months prior to the Pre-selection Visit 1 o Having a clinically significant food allergy that could prevent compliance with the special diet • Any other serious illness or disorder that may affect the life expectancy or hinder the proper management and control of the patient according to the protocol. Presenting hypersensitivity or having a history of adverse reaction to atorvastatin or TAK-475. • Have taken any excluded medication (refer to Section 9.10) within 30 days prior to Prescreening Visit 1 or have plans to take any during the study • To be participating in another research study or to have participated in a research study within 30 days prior to the Pre-selection Visit 1 • Failure to grant the Informed Consent in writing for any reason • Have a level of ALT or AST of> 2 times the upper limit of normal (ULN), active liver disease, jaundice (bilirubin> 1.5 times the upper limit of normal), or serum creatinine> 135 mmol / 1 (1.5 mg / dL), creatine phosphokinase (CPK)> 3 times the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as: • Adverse events • Findings according to the Crystalline Opacity Classification System (LOCS III) • Better Corrected Visual Acuity • Clinical Laboratory Analysis • Vital signs (blood pressure and heart rate) and weight • 12-lead electrocardiogram (ECG) • Physical exam. Measure:Tolerance and Safety Timepoints:Week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Lipid evaluations include the following variables: • Cholesterol bound to low density lipoproteins (LDL-C) • Cholesterol linked to high density lipoproteins (HDL-C) • Total cholesterol (TC) • Triglycerides (TG) • Cholesterol bound to very low density lipoproteins (VLDL-C) • Apolipoprotein Al (Apo Al) • Apolipoprotein B (Apo B) Measure:Changes in blood lipid profiles Timepoints:Week 96 ; Outcome name:The following exploratory laboratory variables will be evaluated: • High sensitivity C-reactive protein (hs-CRP) • Sub-fractionation of lipids (HDL2, HDL3) • Lipoprotein (a). Measure:Change in C-reactive protein, HDL and lipoprotein Timepoints:Week 96 | — |
Countries
Czech Republic, Estonia, Hungary, Latovia, Lithuania, United Kindgdom
Outcome results
None listed