Treatment of patients with primary dyslipidemia MedDRA version: 7 Level: PT Classification code 10058108
Conditions
Interventions
Product Name: TAK-475
Product Code: TAK-475
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: TAK-475
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10
Sponsors
Takeda Europe R&D Centre Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 years 2. Documented history of dyslipidemia (fasting LDL-C levels = 160 mg/dL (4.15 mmol/L) and triglycerides 1yr due to menopause) 4. In good physical and mental health as determined by a physician on the basis of medical history, physical examination and laboratory results 5. Read and understood the Subject Information Sheet and signed the Informed Consent Form At Visit 2/2.1 during Dietary Run-In subjects must be/have: 6. Fasting LDL-C levels = 130 mg/dL (3.37 mmol/L) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Screening Visit 1 to enter the 6-week Dietary Run-In period the subjects must not be/have: 1. Coronary heart disease (CHD) or CHD-risk factors comprised of: 1.1 Diabetes mellitus Type I or II 1.2 History or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischaemic attacks or cerebrovascular accident 2. A body mass index (BMI) 35 kg/m2 3.A history or presence of: 1.1 Drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as routinely consumes > 21 units of alcohol per week) within the 2 years previous to screening. For a definition of a unit of alcohol see section 9.11 1.2 Uncontrolled hypertension despite medical treatment (Stage 2 hypertension defined as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood pressure > 160mmHg) 1.3 Thyroid disease, particularly hyperthyroidism or subjects whose thyroid replacement therapy was initiated within the last 3 months 1.4 HIV positive status, hepatitis B or C 1.5 Malignancy, except subjects whose malignancy has been diagnosed as Stage 1 basal or squamous cell carcinoma 1.6 Heterozygous or homozygous familial hypercholesteroleamia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) 1.7 Fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or discontinuation of HMG-CoA reductase inhibitors due to myalgia 1.8 Trauma to the eye or eye irradiation, glaucoma, iritis, uveitis, prior intraocular surgery, laser surgery to the iris, retinal photocoagulation, or laser trabeculoplasty, corneal opacification or other medial opacities, or has received LASIK refractive surgery within 6 months prior to screening 1.9 A clinically significant food allergy that would prevent adherence to the specialised diet 4. Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and monitor the subject according to the protocol 5. A known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475 6. Taken any excluded medication (see Section 9.10) in the 30 days prior to Screening Visit 1 or be planning to take any for the duration of the study 7. Taking part in another investigational study or have been participating in an investigational study within the 30 days prior to Screening Visit 1 8. Unable to give written informed consent for any reason 9. An ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5 times the ULN) or serum creatinine > 135 µmol/l (1.5 mg/dl), CPK > 3 times the ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall safety and tolerability of once-daily dosing of 100 mg TAK-475 alone, once-daily dosing of 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily dosing of atorvastatin alone over 96 weeks of treatment in patients with primary dyslipidemia.;Secondary Objective: To assess the fasting blood lipid profiles of once-daily dosing of 100 mg TAK-475 alone, once-daily dosing of 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily dosing of atorvastatin alone over 96 weeks of treatment in patients with primary dyslipidemia;Primary end point(s): 1. Primary Objective To evaluate the overall safety and tolerability of once-daily 100 mg TAK-475 alone, oncedaily 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily 10mg atorvastatin alone over 96 weeks in subjects with primary dyslipidemia. 2. Secondary Objective To assess the fasting blood lipid profiles of once-daily 100 mg TAK-475 alone, once-daily 100 mg TAK-475 co-administered with 10 mg atorvastatin and once-daily 10 mg atorvastatin alone over 96 weeks in subjects with primary dyslipidemia. 3. Endpoints 3.1 Safety Variables The safety assessments include the following variables: • Adverse Events • Lens Opacity Classification System (LOCS III) findings • Best Corrected Visual Acuity (BCVA) • Clinical Laboratory Tests • Vital signs (blood pressure and pulse rate) and weight • 12-lead electrocardiogram (ECG) • Physical Examination. 3.2 Lipid Variables The lipid assessments includes the following variables: • Low density lipoprotein cholesterol (LDL-C) • High density lipoprotein cholesterol (HDL-C) • Total Cholesterol (TC) • Triglycerides (TG) • Very low density lipoprotein cholesterol (VLDL-C) • Apolipoprotein A1 (Apo A1) • Apolipoprotein B (Apo B). 3.3 Exploratory Variables The following exploratory laboratory assessments will be evaluated: • High sensitivity C-reactive protein (hs-CRP) • Lipid sub-fractionation (HDL2, HDL3) • Lipoprotein ( | — |
Countries
Czech Republic, Estonia, Hungary, Latvia, Lithuania, United Kingdom
Outcome results
None listed