A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor (AMG 145 20110116)

Phase 3

Completed

• Conditions: hypercholesterolemia; elevate cholesterol; 10000546

• Registration Number: NL-OMON37175
• Lead Sponsor: Amgen BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

* Females (non-child-bearing potential or adequate contraception) and males 18-80 (inclusive) years of age.
* Currently no statin or low-dose statin (see protocol page 44 for details).
* Fasting LDL-C at screening:
a) * 2.6 mmol/L with diagnosed CHD or are CHD risk equivalent or
b) * 3.4 mmol/L without diagnosed CHD or risk equivalent and 2 or more risk factors or
c) * 4.1 mmol/L without diagnosed CHD or risk equivalent and with 1 or no risk factors
* Statin intolerance (see protocol page 44 for details).
* Stable lipid lowering therapy prior to LDL-C screening for * 4 weeks if currently on a statin and/or bile-acid sequestering resin and/or stanol; ezetimibe must be discontinued for * 4 weeks before LDL-C screening.
* Fasting triglycerides * 4.5 mmol/L.

Exclusion Criteria

* NYHA III or IV heart failure, or known left ventricular ejection fraction < 30%.
* Uncontrolled cardiac arrhythmia, see protocol page 45 for details.
* Myocardial infarction, unstable angina, PCI, CABG or stroke within 3 months prior to randomization.
* Planned CABG or PCI.
* Type 1 diabetes or newly diagnosed (within 6 months of randomization) type 2 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.
* Red yeast rice, > 200 mg niacin daily or prescription lipid-regulating drugs (eg, fibrates and derivatives) other than statins, ezetimibe, bile-acid sequestering resin, stanols and stanol esters in the past 6 weeks.
* CETP inhibitor in the last 12 months.
* Active infection.
* 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.</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.</p><br>