Trials / Completed
CompletedNCT01764633
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 27,564 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. |
| DRUG | Placebo | Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. |
Timeline
- Start date
- 2013-02-08
- Primary completion
- 2016-11-11
- Completion
- 2016-11-11
- First posted
- 2013-01-09
- Last updated
- 2024-05-28
- Results posted
- 2018-02-15
Locations
1,284 sites across 49 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01764633. Inclusion in this directory is not an endorsement.