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NCT01288469 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT01288469 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 92 participants.
The verdict
NCT01288469, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.
Interventions
- DRUG Alirocumab
- DRUG Atorvastatin
- DRUG Placebo (for alirocumab)
- DRUG Placebo (for atorvastatin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288469
The ClinicalTrials.gov registry entry for NCT01288469 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 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 4 interventions - of which Alirocumab is the first listed.
NCT01288469 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288469 about?
NCT01288469 is a clinical study titled "Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia". Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10...
What is the current status of trial NCT01288469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2011-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01288469?
The interventions under investigation include: Alirocumab (DRUG), Atorvastatin (DRUG), Placebo (for alirocumab) (DRUG), Placebo (for atorvastatin) (DRUG).
Who is sponsoring clinical trial NCT01288469?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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