Stable AnginaPhase 2NCT02575833
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
A Phase 2 study testing Erenumab in people with Stable Angina, run by Amgen at 33 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 33 sitesin 10 countries
- Study dates
- 23 Nov 2015to 13 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
United States8 sites
Research Site
Atlanta, Georgia, 30342
Research Site
Chicago, Illinois, 60616
Research Site
Jackson, Tennessee, 38305
Research Site
Jacksonville, Florida, 32216
Research Site
Las Vegas, Nevada, 89128
Research Site
Miami, Florida, 33125
Research Site
New Braunfels, Texas, 78130
Research Site
Wichita Falls, Texas, 76301
Slovakia8 sites
Research Site
Bardejov, 085 01
Research Site
Brezno, 977 42
Research Site
Lučenec, 984 01
Research Site
Piešťany, 921 01
Research Site
Prešov, 080 01
Research Site
Svidník, 089 01
Research Site
Trenčín, 911 01
Research Site
Žilina, 010 01
Bulgaria4 sites
Research Site
Haskovo, 6300
Research Site
Sofia, 1407
Research Site
Sofia, 1431
Research Site
Sofia, 1606
Czechia4 sites
Research Site
Brandýs nad Labem, 250 01
Research Site
Chomutov, 430 02
Research Site
Prague, 140 21
Research Site
Pribram VIII, 261 01
Poland3 sites
Research Site
Krakow, 31-202
Research Site
Lodz, 91-347
Research Site
Zabrze, 41-800
New Zealand2 sites
Research Site
Christchurch, 8011
Research Site
Grafton, Auckland, 1023
About this study
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
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.
- Conditions
- Stable Angina
- Being tested
- Erenumab, Placebo
- Keywords
- Angina, Stable Angina, Cardiovascular Disease, Exercise-induced Angina
- Medical subject headings
- Angina, Stable, Angina Pectoris, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
Also called AMG 334, Aimovig™
A single dose of erenumab 140 mg infused over approximately 60 minutes.
PlaceboDrug
A single dose of a matching volume of placebo infused over approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received a single dose of placebo administered by intravenous infusion on day 1. Receives: Drug: Placebo |
| Erenumab | Experimental | Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1. Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Exercise Time
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.
Measured: Baseline and day 1, after dosing
Secondary outcomes (2)
Time to Onset of Exercise-induced Angina
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.
Measured: Day 1
Time to Onset of ≥ 1 mm ST-segment Depression
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start23 Nov 2015
- Primary completion23 Jan 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575833
- Sponsor's protocol ID
- 20140254
- Other IDs
- 2015-002322-40, 2015
- Status last verified
- Jul 2018
- First submitted
- 7 Oct 2015
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA, Mikol DD. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients With Stable Angina. Headache. 2018 May;58(5):715-723. doi: 10.1111/head.13316.
PubMed 29878340
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02575833
- Acronym / sponsor ID
- 20140254
- Conditions
- Stable Angina
- Keywords
- Angina, Stable Angina, Cardiovascular Disease, Exercise-induced Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single dose of placebo administered by intravenous infusion on day 1. |
| Erenumab | Experimental | Drug: ErenumabParticipants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabAlso: AMG 334, Aimovig™A single dose of erenumab 140 mg infused over approximately 60 minutes. | Drug | Erenumab |
| PlaceboA single dose of a matching volume of placebo infused over approximately 60 minutes. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Time to Onset of Exercise-induced Angina
Time frame: Day 1
Time to Onset of ≥ 1 mm ST-segment Depression
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29878340Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA, Mikol DD. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Erenumab on Exercise Time During a Treadmill Test in Patients With Stable Angina. Headache. 2018 May;58(5):715-723. doi: 10.1111/head.13316.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erenumab in people with Stable Angina, run by Amgen at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Slovakia, Bulgaria, Czechia, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Exercise Time (time frame: Baseline and day 1, after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.