A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Total Exercise Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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
Arms & Interventions
Placebo
Participants received a single dose of placebo administered by intravenous infusion on day 1.
Intervention: Placebo (Drug)
Erenumab
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
Intervention: Erenumab (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Total Exercise Time
Time Frame: 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 Outcomes
- Time to Onset of Exercise-induced Angina(Day 1)
- Time to Onset of ≥ 1 mm ST-segment Depression(Day 1)