Phase 2 Completed N=89 Randomized Quadruple-blind Treatment

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Angina

Source: ClinicalTrials.gov NCT02575833 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Jul 2018

Primary outcomePrimary: Change From Baseline in Total Exercise Time — 8.1; -2.9 seconds

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Total Exercise Time	8.1; -2.9	—
SECONDARY Time to Onset of Exercise-induced Angina	508.0; 500.0	0.69
SECONDARY Time to Onset of ≥ 1 mm ST-segment Depression	420.0; 407.0	0.59

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

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Data sourced from ClinicalTrials.gov (NCT02575833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.