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NCT01813422 · ClinicalTrials.gov registry record · Phase 3
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
A Phase 3 study of Hypercholesterolemia, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 970
- Enrollment target
- 20
- Study locations
NCT01813422: Completed Phase 3 study of Hypercholesterolemia, sponsored by Amgen.
NCT01813422 is a Phase 3 study of Hypercholesterolemia that has completed, run by Amgen. The registered enrollment target is 970 participants, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01813422, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 970 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Evolocumab
Study Locations (20)
California
- Research Site - La Jolla
- Research Site - La Jolla
- Research Site - Long Beach
- Research Site - Newport Beach
- Research Site - Orange
- Research Site - San Diego
- Research Site - Santa Monica
- Research Site - Torrance
Florida
- Research Site - Atlantis
- Research Site - Clearwater
- Research Site - Jacksonville
- Research Site - Jacksonville
- Research Site - Melbourne
- Research Site - Safety Harbor
Alabama
- Research Site - Huntsville
- Research Site - Mobile
Arkansas
- Research Site - Little Rock
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Atlanta
Indiana
- Research Site - Hammond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 970 participants |
| Start Date | 2013-04-18 |
| Est. Completion | 2016-07-29 |
| Phase | Phase 3 |
What the finished NCT01813422 record still lists
NCT01813422 is an interventional study that assigns participants to a tested intervention. The registered 970 participants enrollment target is mid-sized for trials with a published cap, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01813422 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01813422 about?
NCT01813422 is a clinical study titled "GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound". 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.
What is the current status of trial NCT01813422?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 970 participants. The study started on 2013-04-18. Estimated completion is 2016-07-29.
What conditions does trial NCT01813422 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01813422?
The interventions under investigation include: Placebo (DRUG), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01813422?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01813422 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01813422's enrollment target sits among peer trials
970 12th of 62 higher than 51 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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