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NCT01288443 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT01288443 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 183 participants.
The verdict
NCT01288443, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study Summary
Primary Objective: * To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab
Interventions
- DRUG Alirocumab
- DRUG Atorvastatin
- DRUG Placebo (for alirocumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288443
The ClinicalTrials.gov registry entry for NCT01288443 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Alirocumab is the first listed.
NCT01288443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288443 about?
NCT01288443 is a clinical study titled "Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy". Primary Objective: * To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Object...
What is the current status of trial NCT01288443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2011-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01288443?
The interventions under investigation include: Alirocumab (DRUG), Atorvastatin (DRUG), Placebo (for alirocumab) (DRUG).
Who is sponsoring clinical trial NCT01288443?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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