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Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia

NCT ID: NCT00729027

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1015 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a screening phase up to 2 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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25 mg/day AVE5530

Group Type EXPERIMENTAL

25 mg/day AVE5530

Intervention Type DRUG

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

50 mg/day AVE5530

Group Type EXPERIMENTAL

50 mg/day AVE5530

Intervention Type DRUG

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Interventions

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25 mg/day AVE5530

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Intervention Type DRUG

50 mg/day AVE5530

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Intervention Type DRUG

placebo

* one tablet in the evening with dinner
* in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults with cholesterol levels not controlled on ongoing stable statin treatment

Exclusion Criteria

* LDL-C levels \> 250 mg/dL (6.48 mmol/L)
* Triglycerides \>350 mg/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
* 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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mats ERICKSSON, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Huddinge, Sweden

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Netanya, , Israel

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Lysaker, , Norway

Site Status

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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United States Australia Belgium Canada Czechia Denmark France Germany Hungary Israel Netherlands Norway Poland Russia Spain Sweden

Other Identifiers

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EudraCT: 2008-001550

Identifier Type: -

Identifier Source: secondary_id

EFC6910

Identifier Type: -

Identifier Source: org_study_id

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