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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02575833




Registration number
NCT02575833
Ethics application status
Date submitted
7/10/2015
Date registered
15/10/2015
Date last updated
24/08/2018

Titles & IDs
Public title
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Scientific 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
Secondary ID [1] 0 0
2015-002322-40
Secondary ID [2] 0 0
20140254
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stable Angina 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Erenumab
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Participants received a single dose of placebo administered by intravenous infusion on day 1.

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


Treatment: Drugs: Erenumab
A single dose of erenumab 140 mg infused over approximately 60 minutes.

Treatment: Drugs: Placebo
A single dose of a matching volume of placebo infused over approximately 60 minutes.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and day 1, after dosing
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Day 1

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Haskovo
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
Czechia
State/province [9] 0 0
Brandys nad Labem
Country [10] 0 0
Czechia
State/province [10] 0 0
Chomutov
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 4
Country [12] 0 0
Czechia
State/province [12] 0 0
Pribram VIII
Country [13] 0 0
Latvia
State/province [13] 0 0
Riga
Country [14] 0 0
New Zealand
State/province [14] 0 0
Christchurch
Country [15] 0 0
New Zealand
State/province [15] 0 0
Grafton, Auckland
Country [16] 0 0
Poland
State/province [16] 0 0
Krakow
Country [17] 0 0
Poland
State/province [17] 0 0
Lodz
Country [18] 0 0
Poland
State/province [18] 0 0
Zabrze
Country [19] 0 0
Romania
State/province [19] 0 0
Timisoara
Country [20] 0 0
Slovakia
State/province [20] 0 0
Bardejov
Country [21] 0 0
Slovakia
State/province [21] 0 0
Brezno
Country [22] 0 0
Slovakia
State/province [22] 0 0
Lucenec
Country [23] 0 0
Slovakia
State/province [23] 0 0
Piestany
Country [24] 0 0
Slovakia
State/province [24] 0 0
Presov
Country [25] 0 0
Slovakia
State/province [25] 0 0
Svidnik
Country [26] 0 0
Slovakia
State/province [26] 0 0
Trencin
Country [27] 0 0
Slovakia
State/province [27] 0 0
Zilina
Country [28] 0 0
South Africa
State/province [28] 0 0
Western Cape
Country [29] 0 0
Switzerland
State/province [29] 0 0
Geneva 14

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02575833
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications