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Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Primary Purpose

Stable Angina

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erenumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Angina, Stable Angina, Cardiovascular Disease, Exercise-induced Angina

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Erenumab

Arm Description

Participants received a single dose of placebo administered by intravenous infusion on day 1.

Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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).

Full Information

First Posted
October 7, 2015
Last Updated
July 27, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02575833
Brief Title
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina
Keywords
Angina, Stable Angina, Cardiovascular Disease, Exercise-induced Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a single dose of placebo administered by intravenous infusion on day 1.
Arm Title
Erenumab
Arm Type
Experimental
Arm Description
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
Intervention Type
Drug
Intervention Name(s)
Erenumab
Other Intervention Name(s)
AMG 334, Aimovig™
Intervention Description
A single dose of erenumab 140 mg infused over approximately 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single dose of a matching volume of placebo infused over approximately 60 minutes.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Exercise Time
Description
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 Outcome Measure Information:
Title
Time to Onset of Exercise-induced Angina
Description
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
Title
Time to Onset of ≥ 1 mm ST-segment Depression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Site
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Research Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Research Site
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Research Site
City
Chomutov
ZIP/Postal Code
430 02
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Pribram VIII
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Grafton, Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300244
Country
Romania
Facility Name
Research Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Research Site
City
Brezno
ZIP/Postal Code
977 42
Country
Slovakia
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Research Site
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Research Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Research Site
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Research Site
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Research Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29878340
Citation
Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA, Mikol DD. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients With Stable Angina. Headache. 2018 May;58(5):715-723. doi: 10.1111/head.13316.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

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