Overview
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Status:
Completed
Completed
Trial end date:
2017-04-13
2017-04-13
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AmgenTreatments:
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