NCT02575833

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Completed Phase 2 Results posted Last updated 24 August 2018

What this trial tests

Phase 2 trial testing Erenumab in Stable Angina in 89 participants. Completed in 13 April 2017.

Timeline

23 November 2015

Primary endpoint
23 January 2017

13 April 2017

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	89
Start date	23 November 2015
Primary completion	23 January 2017
Estimated completion	13 April 2017
Sites	33 locations across New Zealand, South Africa, Slovakia, Poland, Romania, Switzerland, Bulgaria, Czechia

Drugs / interventions tested

• Erenumab (ERENUMAB) — full drug profile →
• Placebo

Conditions studied

• Stable Angina — all drugs for Stable Angina →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 85, any sex, with Stable Angina. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Total Exercise Time Primary · 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.

Group	Value	95% CI
Placebo	8.1	± 14.4
Erenumab	-2.9	± 14.8

Time to Onset of Exercise-induced Angina Secondary · 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.

Group	Value	95% CI
Placebo	508.0	405.0 – 572.0
Erenumab	500.0	420.0 – 540.0

Time to Onset of ≥ 1 mm ST-segment Depression Secondary · 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).

Group	Value	95% CI
Placebo	420.0	409.0 – 480.0
Erenumab	407.0	380.0 – 443.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/44 (2%)

Deaths: 0/44

Erenumab 140 mg

Serious: 0/44 (0%)

Deaths: 0/44

Serious adverse events (1 terms)

Reaction	System	Placebo	Erenumab 140 mg
Atrial fibrillation	Cardiac disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Placebo	Erenumab 140 mg
Influenza	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Hypotension	Vascular disorders	—	—

Most-reported serious reactions: Atrial fibrillation.

Data from ClinicalTrials.gov NCT02575833 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.