Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

July 27, 2018 updated by: Amgen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
  • Czechia
      • Brandys nad Labem, Czechia, 250 01
        • Research Site
      • Chomutov, Czechia, 430 02
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Pribram VIII, Czechia, 261 01
        • Research Site
  • Latvia
      • Riga, Latvia, 1038
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
  • Poland
      • Krakow, Poland, 31-202
        • Research Site
      • Lodz, Poland, 91-347
        • Research Site
      • Zabrze, Poland, 41-800
        • Research Site
  • Romania
      • Timisoara, Romania, 300244
        • Research Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Brezno, Slovakia, 977 42
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Piestany, Slovakia, 921 01
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Svidnik, Slovakia, 089 01
        • Research Site
      • Trencin, Slovakia, 911 01
        • Research Site
      • Zilina, Slovakia, 010 01
        • Research Site
  • South Africa
    • Western Cape
      • Parow, Western Cape, South Africa, 7505
        • Research Site
  • Switzerland
      • Geneva 14, Switzerland, 1211
        • Research Site
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
    • Texas
      • New Braunfels, Texas, United States, 78130
        • Research Site
      • Wichita Falls, Texas, United States, 76301
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received a single dose of placebo administered by intravenous infusion on day 1.
Drug: Placebo
A single dose of a matching volume of placebo infused over approximately 60 minutes.
Experimental: Erenumab
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
Drug: Erenumab
A single dose of erenumab 140 mg infused over approximately 60 minutes.
Other Names:
  • AMG 334
  • Aimovig™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and day 1, after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2015

Primary Completion (Actual)

January 23, 2017

Study Completion (Actual)

April 13, 2017

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140254
  • 2015-002322-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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