Statements (86)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Clinical_Trials
|
| gptkbp:adverse_effects_monitored |
liver function tests
|
| gptkbp:advocacy |
informed consent obtained
|
| gptkbp:analysis |
intention-to-treat
intention-to-treat analysis |
| gptkbp:analytics |
gptkb:SAS
|
| gptkbp:blinding_method |
double-blind
|
| gptkbp:business_model |
obtained from institutional review boards
|
| gptkbp:clinical_trial |
gptkb:FOURIER_Trial
gptkb:ODYSSEY_Outcomes_Trial gptkb:FOURIER_trial Phase 3 Phase III important for managing high-risk patients NCT01476164 NCT01178145 |
| gptkbp:collaborator |
multiple academic institutions
|
| gptkbp:collection |
2010-2014
clinical assessments randomized controlled trial |
| gptkbp:committee |
independent committee
|
| gptkbp:completed |
gptkb:2014
|
| gptkbp:criteria |
pregnancy
severe liver disease age 50 and older history of myopathy patients with acute coronary syndrome |
| gptkbp:duration |
approximately 7 years
|
| gptkbp:eligibility |
patients with acute coronary syndrome
|
| gptkbp:events |
7 years
median of 6 years |
| gptkbp:finale_date |
composite of cardiovascular death, myocardial infarction, and stroke
|
| gptkbp:focuses_on |
gptkb:Cardiology
|
| gptkbp:follow_up_method |
telephone interviews
|
| gptkbp:funding |
gptkb:pharmaceuticals
public and private sources |
| gptkbp:future_prospects |
long-term effects of treatment
exploration of new therapies impact on different populations explore long-term effects of treatment |
| gptkbp:has_limitations |
potential for selection bias
short follow-up for some patients generalizability to other populations |
| https://www.w3.org/2000/01/rdf-schema#label |
IMPROVE-IT Trial
|
| gptkbp:intervention_duration |
at least 6 months
|
| gptkbp:investigates |
gptkb:Dr._Robert_J._Glynn
|
| gptkbp:is_studied_in |
randomized controlled trial
multicenter, randomized, double-blind |
| gptkbp:is_tested_for |
Phase 3
|
| gptkbp:location |
multiple countries
|
| gptkbp:long_term_follow_up |
ongoing studies
|
| gptkbp:members |
simvastatin alone
|
| gptkbp:notable_work |
benefit of combination therapy
ezetimibe added to statin therapy is beneficial |
| gptkbp:objective |
evaluate efficacy of ezetimibe
|
| gptkbp:participants |
18,144
reduction in cardiovascular events mortality, morbidity |
| gptkbp:patient_population |
diverse population
|
| gptkbp:prevention |
gptkb:ezetimibe
gptkb:simvastatin |
| gptkbp:primary_hypothesis |
ezetimibe plus simvastatin is superior to simvastatin alone
|
| gptkbp:provides_guidance_on |
influenced treatment guidelines for dyslipidemia
|
| gptkbp:provides_information_on |
available upon request
data available upon request |
| gptkbp:publication |
peer-reviewed
positive results peer-reviewed article |
| gptkbp:published_in |
gptkb:New_England_Journal_of_Medicine
gptkb:2015 |
| gptkbp:randomization_method |
computer-generated random numbers
|
| gptkbp:recruitment |
completed ahead of schedule
|
| gptkbp:result |
showed significant reduction in major cardiovascular events
significant reduction in major cardiovascular events |
| gptkbp:risk_factor |
hypertension, diabetes, smoking
|
| gptkbp:sample_size_calculation |
based on expected event rates
|
| gptkbp:secondary_outcomes |
need for revascularization
quality of life measures hospitalization for unstable angina |
| gptkbp:side_effect |
mild to moderate
|
| gptkbp:sponsored_by |
gptkb:Merck_&_Co.
|
| gptkbp:started_in |
gptkb:2010
|
| gptkbp:statistical_significance |
p<0.001
|
| gptkbp:study_population |
patients with high cardiovascular risk
|
| gptkbp:treatment |
gptkb:ezetimibe_plus_simvastatin
|
| gptkbp:year |
2014-12-31
|