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NCT01623115 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 486
- Enrollment target
NCT01623115 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 486 participants.
The verdict
NCT01623115, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 486 participants
- Enrollment target
Study Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points * To evaluate the effects of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab
Interventions
- DRUG Alirocumab
- DRUG Placebo (for alirocumab)
- DRUG Lipid Modifying Therapy (LMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623115
The ClinicalTrials.gov registry entry for NCT01623115 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 486 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.
NCT01623115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01623115 about?
NCT01623115 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison...
What is the current status of trial NCT01623115?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2012-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01623115?
The interventions under investigation include: Alirocumab (DRUG), Placebo (for alirocumab) (DRUG), Lipid Modifying Therapy (LMT) (DRUG).
Who is sponsoring clinical trial NCT01623115?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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