Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

• Status: Completed
• Trial end date: 2017-04-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

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