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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: Clinical Trial Phase 3 study, sponsored by Sanofi.

NCT00766688 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 643 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 643 participants
Start Date 2008-10
Est. Completion 2009-06
Phase Phase 3
Sanofi

713 total trials

Why NCT00766688 stopped before completion

NCT00766688 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00766688 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00766688's enrollment target sits among peer trials

643 573rd of 2000 higher than 1,427 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00766688, the US trial registry maintained by the National Library of Medicine. NCT00766688 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.