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Completed

NCT Number: NCT02575833

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Haskovo, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erenumab

Drug

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

Other names: AMG 334, Aimovig™

Placebo

Drug

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

Primary outcomes

  1. Change From Baseline in Total Exercise Time

    Time frame: Baseline and day 1, after dosing

    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.

Secondary outcomes

  1. Time to Onset of Exercise-induced Angina

    Time frame: Day 1

    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.

  2. Time to Onset of ≥ 1 mm ST-segment Depression

    Time frame: Day 1

    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).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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