Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Stable Angina Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575833
• Other study ID #: 20140254
• Secondary ID: 2015-002322-40
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2015
• Est. completion date: April 13, 2017

Study information

• Verified date: July 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 13, 2017
• Est. primary completion date: January 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Intervention

Drug:
• Erenumab
A single dose of erenumab 140 mg infused over approximately 60 minutes.
• Placebo
A single dose of a matching volume of placebo infused over approximately 60 minutes.

Locations

Country	Name	City	State
Bulgaria	Research Site	Haskovo
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Chomutov
Czechia	Research Site	Praha 4
Czechia	Research Site	Pribram VIII
Latvia	Research Site	Riga
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Grafton, Auckland
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Zabrze
Romania	Research Site	Timisoara
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Brezno
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Piestany
Slovakia	Research Site	Presov
Slovakia	Research Site	Svidnik
Slovakia	Research Site	Trencin
Slovakia	Research Site	Zilina
South Africa	Research Site	Parow	Western Cape
Switzerland	Research Site	Geneva 14
United States	Research Site	Atlanta	Georgia
United States	Research Site	Chicago	Illinois
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Miami	Florida
United States	Research Site	New Braunfels	Texas
United States	Research Site	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Latvia,  New Zealand,  Poland,  Romania,  Slovakia,  South Africa,  Switzerland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1
Secondary	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).	Day 1

External Links

•   AmgenTrials clinical trials website