Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Study Overview
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Brief Summary
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A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise time during an exercise treadmill test.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina

Conditions
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Stable Angina

Intervention / Treatment
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* Drug: Erenumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria History of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month Ischemic heart disease documented by myocardial infarction, coronary angiography or a revascularization procedure Receiving stable doses of cardiac medication Completes 2 exercise treadmill tests during screening meeting protocol requirements Exclusion Criteria: Participating in another investigational study Current or prior malignancy within 5 years of randomization Known sensitivity to any components of the investigational product Not able to complete all protocol required study visits Having the following within 3 months prior to or during screening: Unstable angina or acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization procedure, or instability in ST-segment depression between screening exercise treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received a single dose of placebo administered by intravenous infusion on day 1. | Drug: Placebo<br>* A single dose of a matching volume of placebo infused over approximately 60 minutes.<br>|
| Experimental: Erenumab<br>Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1. | Drug: Erenumab<br>* A single dose of erenumab 140 mg infused over approximately 60 minutes.<br>* Other names: Aimovig™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Exercise Time | Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol. The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes. | Baseline and day 1, after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of Exercise-induced Angina | Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time. | Day 1 | 
| Time to Onset of ≥ 1 mm ST-segment Depression | Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time. Heart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG). | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina, Stable Angina, Cardiovascular Disease, Exercise-induced Angina