Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Amgen89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stable Angina

Interventions

ErenumabDRUG

A single dose of erenumab 140 mg infused over approximately 60 minutes.

PlaceboDRUG

A single dose of a matching volume of placebo infused over approximately 60 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (33)

Research Site

Outcomes

Primary Outcomes

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.

Time frame: Baseline and day 1, after dosing

Secondary Outcomes

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.

Time frame: 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).

Time frame: Day 1

Data from ClinicalTrials.gov

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