TerminatedNCT00741715Updated May 16, 2016

Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

A Phase 3 interventional study of AVE5530 and atorvastatin in Hypercholesterolemia, sponsored by Sanofi. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-16.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Why this study was terminated

AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy

Phase: Phase 3
Study type: Interventional
Enrollment: 1,736
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

Read the detailed description

The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.

Conditions studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,267

Keywords

primary hypercholesterolemia

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's enrollment of 1,736 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

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Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy

Exclusion criteria

Exclusion Criteria:

LDL-C levels > 250 mg/dL (6.48 mmol/L)
Triglycerides levels > 350mg/dL (3.95 mmol/L)
Conditions / situations such as:
- presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
- Active liver disease
- High estimated risk of Coronary Heart Disease
- Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
Pregnant or breast-feeding women,
Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
Hypersensitivity to any component of atorvastatin
Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,736 participants (actual)

Study arms

Placebo comparator
1
Drug: placebo
Experimental
2
AVE5530 25mg
Drug: AVE5530
Experimental
3
AVE5530 50mg
Drug: AVE5530
Active comparator
4
atorvastatin 10mg
Drug: atorvastatin
Experimental
5
atorvastatin 10mg + AVE5530 25mg
Drug: AVE5530 · Drug: atorvastatin
Experimental
6
atorvastatin 10mg + AVE5530 50mg
Drug: AVE5530 · Drug: atorvastatin
Active comparator
7
atorvastatin 20mg
Drug: atorvastatin
Experimental
8
atorvastatin 20mg + AVE5530 25mg
Drug: AVE5530 · Drug: atorvastatin
Experimental
9
atorvastatin 20mg + AVE5530 50mg
Drug: AVE5530 · Drug: atorvastatin
Active comparator
10
atorvastatin 40mg
Drug: atorvastatin
Experimental
11
atorvastatin 40mg + AVE5530 25mg
Drug: AVE5530 · Drug: atorvastatin
Experimental
12
atorvastatin 40mg + AVE5530 50mg
Drug: AVE5530 · Drug: atorvastatin
Active comparator
13
atorvastatin 80mg
Drug: atorvastatin
Experimental
14
atorvastatin 80mg + AVE5530 25mg
Drug: AVE5530 · Drug: atorvastatin
Experimental
15
atorvastatin 80mg + AVE5530 50mg
Drug: AVE5530 · Drug: atorvastatin

Interventions

DrugAVE5530
oral administration once daily in the evening with dinner
Drugatorvastatin
oral administration once daily in the evening with dinner
Drugplacebo
oral administration once daily in the evening with dinner

What researchers measure

Primary outcomes

Percent change from baseline in calculated LDL-C
Time frame: At week 12

Secondary outcomes

Percent change from baseline in calculated LDL-C
Time frame: At 6 months and 12 months
Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP
Time frame: At week 12, 6 months and 12 months

Study locations

2 sites

Sanofi-Aventis Administrative Office
Bridgewater, New Jersey 08807, United States
Sanofi-Aventis Administrative Office
San Juan, Puerto Rico

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00741715
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Aug 26, 2008
Start date: Aug 2008
Primary completion: May 2009
Completion: Jun 2009
Last update: May 16, 2016

Study contacts

Davidson Michael, MD

principal investigator · Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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