Treatment of patients with primary hypercholesterolemia currently taking atorvastatin (80mg), simvastatin (80mg) or rosuvastatin (40mg) MedDRA version: 8 Level: PT Classification code 10058108
Conditions
Interventions
Product Code: TAK-475
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: TAK-475
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Takeda Europe R&D Centre Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female subjects (non-pregnant and non-lactating) who are at least 18 years of age, who meet the following lipid criteria: • Prior to Randomization, the subject must have a mean LDL-C =100 mg/dL (2.59 mmol/L) for 2 consecutive samples (at least 1 week apart). The difference between the two individual LDL-C values must not exceed 15% of the higher value • Prior to Randomization, the subject must have mean triglycerides =400 mg/dL (4.52 mmol/L) for 2 consecutive samples (at least 1 week apart). The upper value for either sample must be =450 mg/dL (5.1 mmol/L) The subject must be taking the highest recommended dose of an HMG-CoA reductase inhibitor once daily for at least 4 weeks prior to Visit 1. Subjects who are on a stable regimen of ezetimibe, in addition to their HMG-CoA reductase inhibitor will be allowed to participate in the study while continuing the ezetimibe. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not qualify for entry into the study: • if female, are pregnant, lactating, intend to become pregnant during the course of the study, or are unwilling to use acceptable contraception for the course of the study • have elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (>1.5 times the upper limit of normal [ULN]), active liver disease, jaundice, or a history of liver disease • has serum creatinine >135 mmol/L (1.5 mg/dL); • have elevated creatine phosphokinase (>3 times ULN); • has diabetes, with an HbA1c >8% at Visit 1; • have a history of myocardial infarction, unstable angina, transient ischemic attacks, cerebrovascular accident, percutaneous coronary intervention, coronary or peripheral arterial surgery (bypass graft surgery) in the 6 months prior to Visit 1; • have fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain; • have a known hypersensitivity or history of adverse reaction to atorvastatin, rosuvastatin, or simvastatin; • has inflammatory bowel disease or any other malabsorption syndrome or have had gastric bypass or another surgical procedure for weight loss; • have uncontrolled hypertension despite medical treatment (defined as mean resting diastolic blood pressure >100 mm Hg or mean resting systolic blood pressure >160 mm Hg) at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the change in low-density lipoprotein cholesterol (LDL-C) in subjects with primary hypercholesterolemia treated with TAK-475 100 mg QD or placebo QD when coadministered with high dose atorvastatin, rosuvastatin, or simvastatin after 24 weeks of treatment.;Secondary Objective: The secondary objectives are to evaluate: • safety and tolerability (adverse events [AEs], safety laboratory tests, physical exam [PE], vital signs, best corrected visual acuity [BCVA] and electrocardiogram[ECG]) • changes in secondary lipid variables (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], triglycerides [TG], very-low density lipoprotein cholesterol [VLDL-C], apolipoprotein A1 [Apo A1], apolipoprotein B [Apo B], and derived lipid variables). • change in high-sensitivity C-reactive protein (hs-CRP). • the percentage of subjects who achieve LDL-C concentrations of <130, <100 and <70 mg/dL at the final visit. • the long-term safety of TAK-475 treatment in this population during the open-label extension period.;Primary end point(s): The primary efficacy variable for this study is plasma LDL-C. | — |
Countries
Finland, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed