Hypercholesterolemia MedDRA version: 18.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EVOLOCUMAB
Current Sponsor
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, = 50 years of age at the time of informed consent - Subject with fasting Lp(a) = 50 mg/dL at screening 1 - Subject with fasting LDL-C = 100 mg/dL at screening 1 - For those subjects receiving lipid lowering therapy, lipid-lowering therapy, including statin dose, must be unchanged for = 8 weeks prior to screening 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 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: - Known diagnosis of diabetes mellitus or screening fasting serum glucose = 126 mg/dL or HbA1C = 6.5% - A history of homozygous familial hypercholesterolemia - Recent cardiovascular event within 3 months prior to randomization, or planned cardiac surgery, PCI or carotid stenting, or planned major non-cardiac surgery during the course of the study period - Currently undergoing lipid apheresis - Known contraindications or limitations to FDG-PET/ CT - Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent ( 325 mg/day) or NSAIDs (> 1000 mg/day) - Known sensitivity to any of the active substances or excipients to be administered during dosing - Subject has taken a cholesterol ester transfer protein inhibitor or mipomersen or lomitapide in the last 12 months prior to screening - Known systemic disorders or any clinically significant medical condition that could interfere with the conduct of the study - History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years - Subject has previously received evolocumab or any other therapy to inhibit PCSK9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of evolocumab on arterial wall inflammation, as measured by percent change from baseline in target-to-background ratio of an index vessel by FDG-PET/CT at week 16 in subjects with baseline lipoprotein (a) [Lp(a)] = 50 mg/dL and low density lipoprotein-cholesterol (LDL-C) = 100 mg/dL;Secondary Objective: To evaluate the effect of evolocumab on - Lp(a) - LDL-C - Apolipoprotein B (ApoB);Primary end point(s): Percent change from baseline in TBR within the MDS of the index vessel (right carotid, left carotid, or thoracic aorta) by FDG-PET/CT;Timepoint(s) of evaluation of this end point: Baseline, Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): [2EP-1] Percent change in Lp(a) [2EP-2] Percent change in LDL-C [2EP-3] Percent change in ApoB;Timepoint(s) of evaluation of this end point: [2EP-1] Baseline, Day 1, Week 8, Week 16 [2EP-2] Baseline, Day 1, Week 8, Week 16 [2EP-3] Baseline, Day 1, Week 8, Week 16 | — |
Countries
Netherlands
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed