Trials / Completed
CompletedNCT01813422
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 970 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Administered by subcutaneous injection |
| DRUG | Placebo | Administered by subcutaneous injection |
Timeline
- Start date
- 2013-04-18
- Primary completion
- 2016-07-12
- Completion
- 2016-07-29
- First posted
- 2013-03-19
- Last updated
- 2019-02-20
- Results posted
- 2018-01-04
Locations
226 sites across 32 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01813422. Inclusion in this directory is not an endorsement.