Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575833
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : July 4, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stable Angina Drug: Erenumab Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received a single dose of placebo administered by intravenous infusion on day 1.
Drug: Placebo
A single dose of a matching volume of placebo infused over approximately 60 minutes.

Experimental: Erenumab
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
Drug: Erenumab
A single dose of erenumab 140 mg infused over approximately 60 minutes.
Other Names:
  • AMG 334
  • Aimovig™




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


  Hide Study Locations
Locations
Layout table for location information
United States, Florida
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Miami, Florida, United States, 33125
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Research Site
Chicago, Illinois, United States, 60616
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89128
United States, Tennessee
Research Site
Jackson, Tennessee, United States, 38305
United States, Texas
Research Site
New Braunfels, Texas, United States, 78130
Research Site
Wichita Falls, Texas, United States, 76301
Bulgaria
Research Site
Haskovo, Bulgaria, 6300
Research Site
Sofia, Bulgaria, 1407
Research Site
Sofia, Bulgaria, 1431
Research Site
Sofia, Bulgaria, 1606
Czechia
Research Site
Brandys nad Labem, Czechia, 250 01
Research Site
Chomutov, Czechia, 430 02
Research Site
Praha 4, Czechia, 140 21
Research Site
Pribram VIII, Czechia, 261 01
Latvia
Research Site
Riga, Latvia, 1038
New Zealand
Research Site
Christchurch, New Zealand, 8011
Research Site
Grafton, Auckland, New Zealand, 1023
Poland
Research Site
Krakow, Poland, 31-202
Research Site
Lodz, Poland, 91-347
Research Site
Zabrze, Poland, 41-800
Romania
Research Site
Timisoara, Romania, 300244
Slovakia
Research Site
Bardejov, Slovakia, 085 01
Research Site
Brezno, Slovakia, 977 42
Research Site
Lucenec, Slovakia, 984 01
Research Site
Piestany, Slovakia, 921 01
Research Site
Presov, Slovakia, 080 01
Research Site
Svidnik, Slovakia, 089 01
Research Site
Trencin, Slovakia, 911 01
Research Site
Zilina, Slovakia, 010 01
South Africa
Research Site
Parow, Western Cape, South Africa, 7505
Switzerland
Research Site
Geneva 14, Switzerland, 1211
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] April 13, 2017
Statistical Analysis Plan  [PDF] April 13, 2017


Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02575833     History of Changes
Other Study ID Numbers: 20140254
2015-002322-40 ( EudraCT Number )
First Posted: October 15, 2015    Key Record Dates
Results First Posted: July 4, 2018
Last Update Posted: August 24, 2018
Last Verified: July 2018
Keywords provided by Amgen:
Angina
Stable Angina
Cardiovascular Disease
Exercise-induced Angina
Additional relevant MeSH terms:
Layout table for MeSH terms
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Erenumab
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors