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NCT01375764 · ClinicalTrials.gov registry record · Phase 2
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
A Phase 2 study of Hyperlipidemia, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT01375764: Completed Phase 2 study of Hyperlipidemia, sponsored by Amgen.
NCT01375764 is a Phase 2 study of Hyperlipidemia that has completed, run by Amgen. The registered enrollment target is 160 participants, below the 403-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375764, a Phase 2 study of Hyperlipidemia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.
Primary Outcome
LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Conditions Studied
Interventions
- DRUG Ezetimibe
- BIOLOGICAL Evolocumab
- OTHER Placebo to Evolocumab
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Mission Viejo
- Research Site - Westlake Village
Georgia
- Research Site - Atlanta
- Research Site - Atlanta
- Research Site - Savannah
Nevada
- Research Site - Henderson
- Research Site - Las Vegas
Ohio
- Research Site - Akron
- Research Site - Cincinnati
New South Wales
- Research Site - Camperdown
- Research Site - Sydney
Maine
- Research Site - Auburn
Maryland
- Research Site - Chevy Chase
Montana
- Research Site - Butte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-07-28 |
| Est. Completion | 2012-05-08 |
| Phase | Phase 2 |
What the finished NCT01375764 record still lists
NCT01375764 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 403-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 3 interventions - of which Ezetimibe is the first listed.
NCT01375764 names 20 study sites across 13 states, led by California, Georgia, Nevada.
Frequently Asked Questions
What is clinical trial NCT01375764 about?
NCT01375764 is a clinical study titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects". The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.
What is the current status of trial NCT01375764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2011-07-28. Estimated completion is 2012-05-08.
What conditions does trial NCT01375764 study?
This clinical trial studies the following conditions: Hyperlipidemia.
What interventions are being tested in trial NCT01375764?
The interventions under investigation include: Ezetimibe (DRUG), Evolocumab (BIOLOGICAL), Placebo to Evolocumab (OTHER).
Who is sponsoring clinical trial NCT01375764?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01375764 being conducted?
This trial has 20 study locations across California, Georgia, Maine, Maryland, Montana. 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 NCT01375764's enrollment target sits among peer trials
160 17th of 35 higher than 19 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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