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NCT01161082 · ClinicalTrials.gov registry record · Phase 1
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
A Phase 1 study of Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT01161082 is a Phase 1 study of Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 72 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01161082, a Phase 1 study of Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
Conditions Studied
Interventions
- DRUG REGN727(SAR236553)
Study Locations (2)
Ohio
- Site 1 - Cincinnati
Tennessee
- Site 2 - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161082
The ClinicalTrials.gov registry entry for NCT01161082 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (91% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which REGN727(SAR236553) is the first listed.
NCT01161082 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01161082 about?
NCT01161082 is a clinical study titled "Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin". This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcu...
What is the current status of trial NCT01161082?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2010-06. Estimated completion is 2011-05.
What conditions does trial NCT01161082 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01161082?
The interventions under investigation include: REGN727(SAR236553) (DRUG).
Who is sponsoring clinical trial NCT01161082?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01161082 being conducted?
This trial has 2 study locations across Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.