A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
- Conditions
- hypercholesterolemiaelevate cholesterol10013317
- Registration Number
- NL-OMON45082
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
• Females (non-child-bearing potential or adequate contraception) and males 18-80 (inclusive) years of age
• Not at LDL-C goal
• History of statin intolerance
• Lipid lowering therapy has been stable prior to LDL-C screening for at least 4 weeks if currently on a bile-acid sequestering resin and/or stanol
• Fasting triglycerides <= 400 mg/dL (4.52 mmol/L) by central laboratory at screening
• History of haemorrahagic stroke
• Personal or family history of hereditary muscular disorders
• NYHA III or IV heart failure, or last known LVEF < 30%
• Uncontrolled serious cardiac arrhythmia
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
• Planned cardiac surgery or revascularization
• Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes, or laboratory evidence of diabetes during screening
• Uncontrolled hypertension
• Use of red yeast rice, > 200 mg/day niacin, or prescription lipid-regulating drugs (eg, fibrates and derivatives, statins or ezetimibe) other than bile-acid sequestering resin, or stanols and stanol esters
• Use of cholesterylester transfer protein (CETP) inhibitor
• Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions
• Uncontrolled hypothyroidism or hyperthyroidism as defined by TSH < 1.0 time the lower limit of normal or >1.5 times the ULN, respectively, at screening.
• Moderate to severe renal dysfunction
• Active liver disease or hepatic dysfunction
• Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
• Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percent change from baseline in LDL-C after 24 weeks treatment with AMG145 or<br /><br>ezetimibe.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Adverse events, Absolute change from baseline in LDL-C after 24 weeks of<br /><br>treatment, Percent change from baseline after 24 weeks of treatment in:<br /><br>non-HDL-C, ApoB, total cholesterol/HDL-C ratio, ApoB/ApoA1 ratio, Lp(a),<br /><br>triglyceriden, HDL-C, VLDL-C. Percent of subjects attaining LDL-C < 70 mg/dL<br /><br>(1.81 mmol/L).</p><br>