Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
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|ClinicalTrials.gov Identifier: NCT02575833|
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : July 4, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina||Drug: Erenumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||November 23, 2015|
|Actual Primary Completion Date :||January 23, 2017|
|Actual Study Completion Date :||April 13, 2017|
Placebo Comparator: Placebo
Participants received a single dose of placebo administered by intravenous infusion on day 1.
A single dose of a matching volume of placebo infused over approximately 60 minutes.
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
A single dose of erenumab 140 mg infused over approximately 60 minutes.
- 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.
- Time to Onset of Exercise-induced Angina [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575833
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