Hypercholesterolemia MedDRA version: 13.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent. - Male or female = 18 to = 80 years of age - On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks before LDL-C screening and, in the opinion of the investigator, not requiring uptitration - Fasting LDL-C as determined by central laboratory at screening = 85 mg/dL (Note: enrollment of subjects with screening LDL-C between = 85 mg/dL and =65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: - NYHA III or IV heart failure, or known left ventricular ejection fraction 8.5%) - Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg, confirmed with repeat measurement - Subject has taken during > 2 weeks in the last 3 months prior to LDL-C screening: lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, bile-acid sequestering resins; red yeast rice, niacin (> 200 mg/day), or omega-3 fatty acids (>1000 mg/day) - Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: cyclosporine, systemic steroids (IV, intramuscular [IM], or PO), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in a multivitamin preparation is permitted) - Hyperthyroidism or hypothyroidism as defined by TSH below the lower limit of normal (LLN) or >1.5 times the upper limit of normal (ULN), respectively, at screening - Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) 2 times the ULN as determined by central laboratory analysis at screening, confirmed by a repeat measurement at least 1 week apart - CK > 3 times the ULN at screening, confirmed by a repeat measurement at least 1 week apart - Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator - Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization - Current therapeutic anticoagulation with vitamin K antagonist (eg, warfarin), heparin, low-molecular weight heparin, direct thrombin inhibitor, or Factor Xa inhibitor - Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis) - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) - Female subject is not willing to use at least one highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal; postmenopausal is defined as 12 continuous months of spontaneous amenorrhea; highly effective methods include birth control pills, shots, implants, or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every 2 weeks (Q2W) or every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to a statin in subjects with hypercholesterolemia.;Secondary Objective: - To evaluate the safety and tolerability of 6 dose regimens of AMG 145 SC, compared with placebo, when used in combination with a statin in subjects with hypercholesterolemia - To assess the effects of 12 weeks of AMG 145 SC used in combination with a statin, compared with placebo used with a statin, on absolute change in LDL-C, and percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with hypercholesterolemia - To characterize pharmacokinetics of AMG 145 following SC injection in subjects with hypercholesterolemia receiving statin therapy ;Primary end point(s): The percent change from baseline in LDL-C at week 12.;Timepoint(s) of evaluation of this end point: From baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Absolute change from baseline in LDL-C at week 12 - Percent change from baseline in non-HDL-C at week 12 - Percent change from baseline in ApoB at week 12 - Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 - Percent change from baseline in ApoB/ApoA1 ratio at week 12 ;Timepoint(s) of evaluation of this end point: - Absolute change from baseline in LDL-C at week 12:From baseline to week 12 - Percent change from baseline in non-HDL-C at week 12: From baseline to week 12 - Percent change from baseline in ApoB at week 12: From baseline to week 12 - Percent change from baseline in the total cholesterol/HDL-C ratio at week 12: From baseline to week 12 - Percent change from baseline in ApoB/ApoA1 ratio at week 12: From baseline to week 12 | — |
Countries
Canada, Czech Republic, Denmark, Hungary, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed