A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia (AMG 145 20110115)
- Conditions
- dyslipidemiaelevated cholesterol10000546
- Registration Number
- NL-OMON36995
- Lead Sponsor
- Amgen BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
* * 18 to * 80 years of age
* Not taking a statin at screening: fasting LDL-C * 4.0 mmol/L
* Already on a non-intensive statin (see Appendix D) at screening: fasting LDL-C * 2.6 mmol/L
* Already on a intensive statin (see Appendix D) at screening: fasting LDL-C * 2.1 mmol/L
* Fasting triglycerides * 4.5 mmol/L at screening
* Statin intolerance, or any intolerance to rosuvastatin, atorvastatin, or simvastatin
* Personal or family history of hereditary muscular disorders
* Subjects who in the opinion of the investigator, require maximal statin
therapy
* NYHA III or IV heart failure, or known left ventricular ejection fraction < 30%.
* Uncontrolled cardiac arrhythmia, see protocol page 41 for details.
* Myocardial infarction, unstable angina, PCI, CABG or stroke within 6 months prior to randomization.
* Planned CABG or PCI.
* Type 1 diabetes poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes (within 6 months of randomization), laboratory evidence of diabetes during screening (fasting plasma glucose * 7.0 mmol/L or HbA1c * 6.5%) without prior diagnosis of diabetes.
* Uncontrolled hypertension.
* In the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, > 1000 mg/day omega-3 fatty acids (DHA and EPA combined), stanols or prescription lipid-regulating drugs other than statins and ezetimibe
* CETP inhibitor in the last 12 months.
* Active infection.
* DVT or pulmonary embolism in last 3 months.
* Pregnancy, inadequate contraception, breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percent change from baseline in LDL-C at week 12 (versus placebo).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Adverse events, Absolute change from baseline in LDL-C at week 12, Percent<br /><br>change from baseline at week 12 in: non-HDL-C, ApoB total cholesterol/HDL-C<br /><br>ratio ApoB/ApoA1 ratio, Lp(a), triglyceriden, HDL-C. Efficacy parameters versus<br /><br>ezetimibe.</p><br>