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NCT00729027 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,015
- Enrollment target
NCT00729027 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 1,015 participants.
The verdict
NCT00729027, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,015 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 statin treatment in a double-blind manner in comparison with placebo, in the management of patients with 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 25 mg/day AVE5530
- DRUG 50 mg/day AVE5530
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,015 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00729027
The ClinicalTrials.gov registry entry for NCT00729027 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,015 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 placebo is the first listed.
NCT00729027 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00729027 about?
NCT00729027 is a clinical study titled "Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia". The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing s...
What is the current status of trial NCT00729027?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,015 participants. The study started on 2008-07. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00729027?
The interventions under investigation include: placebo (DRUG), 25 mg/day AVE5530 (DRUG), 50 mg/day AVE5530 (DRUG).
Who is sponsoring clinical trial NCT00729027?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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