Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Phase 2

Completed

• Conditions: Stable Angina
• Interventions: Drug: Placebo; Drug: Erenumab

• Registration Number: NCT02575833
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2015-11-23
• Primary Completion: 2017-01-23
• Study Completion: 2017-04-13
• Disposition First Submitted: 2017-11-09
• Disposition First Submitted QC: 2017-11-09
• Disposition First Posted: 2017-11-14
• Results First Submitted: 2018-05-21
• Results First Submitted QC: 2018-06-06
• Status Verified: 2018-07
• Results First Posted: 2018-07-05
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received a single dose of placebo administered by intravenous infusion on day 1.
Erenumab	Erenumab	Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Exercise Time	Baseline and day 1, after dosing	Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol.; The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.

Secondary Outcome Measures

Name	Time	Method
Time to Onset of Exercise-induced Angina	Day 1	Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.
Time to Onset of ≥ 1 mm ST-segment Depression	Day 1	Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.; Heart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG).

Trial Locations

Locations (1)

Research Site; 🇨🇭 Geneva 14, Switzerland