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NCT01380730 · ClinicalTrials.gov registry record · Phase 2
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
A Phase 2 study of Hyperlipidemia, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 631
- Enrollment target
- 20
- Study locations
NCT01380730: Completed Phase 2 study of Hyperlipidemia, sponsored by Amgen.
NCT01380730 is a Phase 2 study of Hyperlipidemia that has completed, run by Amgen. The registered enrollment target is 631 participants, above the 390-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380730, a Phase 2 study of Hyperlipidemia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 631 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
Primary Outcome
LDL-C was measured using ultracentrifugation.
Conditions Studied
Interventions
- BIOLOGICAL Evolocumab
- OTHER Placebo to Evolocumab
Study Locations (20)
Florida
- Research Site - Daytona Beach
- Research Site - Green Cove Springs
- Research Site - Melbourne
- Research Site - Miami
- Research Site - Miami
- Research Site - Port Charlotte
California
- Research Site - Anaheim
- Research Site - Carmichael
- Research Site - Newport Beach
- Research Site - Roseville
- Research Site - Westlake Village
Indiana
- Research Site - Hammond
- Research Site - Indianapolis
- Research Site - Valparaiso
Colorado
- Research Site - Colorado Springs
- Research Site - Littleton
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Tucson
Arkansas
- Research Site - Malvern
Illinois
- Research Site - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 631 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2012-04-05 |
| Phase | Phase 2 |
What the finished NCT01380730 record still lists
NCT01380730 is an interventional study that assigns participants to a tested intervention. The registered 631 participants enrollment target is mid-sized for trials with a published cap, above the 390-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (62% higher).
The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 2 interventions - of which Evolocumab is the first listed.
NCT01380730 names 20 study sites across 8 states, led by Florida, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT01380730 about?
NCT01380730 is a clinical study titled "LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy". To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
What is the current status of trial NCT01380730?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 631 participants. The study started on 2011-07-01. Estimated completion is 2012-04-05.
What conditions does trial NCT01380730 study?
This clinical trial studies the following conditions: Hyperlipidemia.
What interventions are being tested in trial NCT01380730?
The interventions under investigation include: Evolocumab (BIOLOGICAL), Placebo to Evolocumab (OTHER).
Who is sponsoring clinical trial NCT01380730?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01380730 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperlipidemia
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 NCT01380730's enrollment target sits among peer trials
631 6th of 35 higher than 30 of 35 other Hyperlipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperlipidemia 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.
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