Clinical trial NCT02575833: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Angina
Keywords: Angina
Stable Angina
Cardiovascular Disease
Exercise-induced Angina
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Total Exercise Time
timeFrame: Baseline and day 1, after dosing
Secondary outcomes:
measure: Time to Onset of Exercise-induced Angina
timeFrame: Day 1
measure: Time to Onset of ≥ 1 mm ST-segment Depression
timeFrame: Day 1
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: New Braunfels
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Haskovo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Brandys nad Labem
country: Czechia
facility: Research Site
city: Chomutov
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Pribram VIII
country: Czechia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Grafton, Auckland
country: New Zealand
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
state: Western Cape
city: Geneva 14
country: Switzerland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.