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NCT00766688 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
NCT00766688 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 643 participants.
The verdict
NCT00766688, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
Study Summary
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
Interventions
- DRUG Placebo
- DRUG AVE5530
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00766688
The ClinicalTrials.gov registry entry for NCT00766688 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 643 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 2 interventions - of which Placebo is the first listed.
NCT00766688 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00766688 about?
NCT00766688 is a clinical study titled "Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia". The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controll...
What is the current status of trial NCT00766688?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2008-10. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00766688?
The interventions under investigation include: Placebo (DRUG), AVE5530 (DRUG).
Who is sponsoring clinical trial NCT00766688?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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