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Study Complete
Sponsor ID
20140254

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Sponsor ID
20140254
Clinicaltrials.gov ID
NCT02575833
EUCTIS ID
N/A
EudraCT ID
2015-002322-40
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
89
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in total exercise time during an exercise treadmill test in subjects with stable angina.

Timeframe: Within 6 weeks of screening

Secondary Outcome Measures

Time to onset of exercise-induced angina during an exercise treadmill test

Timeframe: Within 6 weeks of screening

Time to onset of > or = 1 mm of ST-segment depression during an exercise treadmill test

Timeframe: Within 6 weeks of screening

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
Location
Research Site
Chicago, IL, United States, 60616
Status
Recruiting
Location
Research Site
Las Vegas, NV, United States, 89128
Status
Recruiting
Location
Research Site
Jacksonville, FL, United States, 32216
Status
Recruiting
Location
Research Site
Wichita Falls, TX, United States, 76301
Status
Recruiting
Location
Research Site
Christchurch, New Zealand, 8011
Status
Recruiting
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Study Info
Age
18 - 85 Years
Condition
  • Angina
    • Sex
    All
    Trial Dates
    Nov 2015 - Jan 2017
    Inclusion and Exclusion Criteria
    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