Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
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
2 other identifiers
interventional
89
10 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2015
Shorter than P25 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2017
CompletedResults Posted
Study results publicly available
July 5, 2018
CompletedAugust 24, 2018
July 1, 2018
1.2 years
October 7, 2015
May 21, 2018
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Time to Onset of Exercise-induced Angina
Day 1
Time to Onset of ≥ 1 mm ST-segment Depression
Day 1
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received a single dose of placebo administered by intravenous infusion on day 1.
Erenumab
EXPERIMENTALParticipants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (33)
Research Site
Jacksonville, Florida, 32216, United States
Research Site
Miami, Florida, 33125, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Chicago, Illinois, 60616, United States
Research Site
Las Vegas, Nevada, 89128, United States
Research Site
Jackson, Tennessee, 38305, United States
Research Site
New Braunfels, Texas, 78130, United States
Research Site
Wichita Falls, Texas, 76301, United States
Research Site
Haskovo, 6300, Bulgaria
Research Site
Sofia, 1407, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Sofia, 1606, Bulgaria
Research Site
Brandýs nad Labem, 250 01, Czechia
Research Site
Chomutov, 430 02, Czechia
Research Site
Prague, 140 21, Czechia
Research Site
Pribram VIII, 261 01, Czechia
Research Site
Riga, 1038, Latvia
Research Site
Christchurch, 8011, New Zealand
Research Site
Grafton, Auckland, 1023, New Zealand
Research Site
Krakow, 31-202, Poland
Research Site
Lodz, 91-347, Poland
Research Site
Zabrze, 41-800, Poland
Research Site
Timișoara, 300244, Romania
Research Site
Bardejov, 085 01, Slovakia
Research Site
Brezno, 977 42, Slovakia
Research Site
Lučenec, 984 01, Slovakia
Research Site
Piešťany, 921 01, Slovakia
Research Site
Prešov, 080 01, Slovakia
Research Site
Svidník, 089 01, Slovakia
Research Site
Trenčín, 911 01, Slovakia
Research Site
Žilina, 010 01, Slovakia
Research Site
Parow, Western Cape, 7505, South Africa
Research Site
Geneva, 1211, Switzerland
Related Publications (1)
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.
PMID: 29878340BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 15, 2015
Study Start
November 23, 2015
Primary Completion
January 23, 2017
Study Completion
April 13, 2017
Last Updated
August 24, 2018
Results First Posted
July 5, 2018
Record last verified: 2018-07