Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-23

Study Completion Date

2017-04-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single dose of a matching volume of placebo infused over approximately 60 minutes.

Erenumab

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

Group Type EXPERIMENTAL

Erenumab

Intervention Type DRUG

A single dose of erenumab 140 mg infused over approximately 60 minutes.

Interventions

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Erenumab

A single dose of erenumab 140 mg infused over approximately 60 minutes.

Intervention Type DRUG

Placebo

A single dose of a matching volume of placebo infused over approximately 60 minutes.

Intervention Type DRUG

Other Intervention Names

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AMG 334 Aimovig™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No