Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Amgen

Status and phase: Completed; Phase 2

Conditions: Stable Angina

Treatments: Drug: Placebo; Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02575833

2015-002322-40 (EudraCT Number)

20140254

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received a single dose of placebo administered by intravenous infusion on day 1.

Treatment:

Drug: Placebo

Erenumab

Experimental group

Description:

Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.

Treatment:

Drug: Erenumab