Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Completed · Phase 2 · Has a placebo group

Conditions studied: Stable Angina

In brief

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.

Key facts

Study ID

NCT02575833

Run by

Amgen

People needed

89

Starts

2015-11-23

Expected to finish

2017-04-13

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Jackson, Tennessee, United States
• Research Site — New Braunfels, Texas, United States
• Research Site — Wichita Falls, Texas, United States
• Research Site — Haskovo, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Brandýs nad Labem, Czechia
• Research Site — Chomutov, Czechia
• Research Site — Prague, Czechia
• Research Site — Pribram VIII, Czechia
• Research Site — Riga, Latvia
• Research Site — Christchurch, New Zealand
• Research Site — Grafton, Auckland, New Zealand
• Research Site — Krakow, Poland
• Research Site — Lodz, Poland
• Research Site — Zabrze, Poland
• Research Site — Timișoara, Romania
• Research Site — Bardejov, Slovakia
• Research Site — Brezno, Slovakia

Full record on ClinicalTrials.gov

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