Evaluation of Safety and Efficacy of AVE5530 as Add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00729027

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: AVE5530 Drug: placebo	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, 12-Month, Placebo-Controlled Study to Evaluate the Lipid-Lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percent change from baseline in calculated LDL-C [ Time Frame: At week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline in calculated LDL-C [ Time Frame: At 6 months and 12 months ] [ Designated as safety issue: No ]
Percent change from baseline in Total-Cholesterol and Apo-B [ Time Frame: At 12 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 25 mg/day	Drug: AVE5530 one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)
2: Experimental 50 mg/day	Drug: AVE5530 one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)
3: Placebo Comparator	Drug: placebo one tablet in the evening with dinner in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729027

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office	Recruiting
Bridgewater, New Jersey, United States, 08807
Contact GV-Contact-us@sanofi-aventis.com
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office	Recruiting
Macquarie Park, New South Wales, Australia
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Belgium
Sanofi-Aventis Administrative Office	Recruiting
Diegem, Belgium
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Canada
Sanofi-Aventis Administrative Office	Recruiting
Laval, Canada
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Czech Republic
Sanofi-Aventis Administrative Office	Recruiting
Praha, Czech Republic
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Denmark
Sanofi-Aventis Administrative Office	Recruiting
Horsholm, Denmark
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France
Sanofi-Aventis Administrative Office	Recruiting
Paris, France
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Germany
Sanofi-Aventis Administrative Office	Recruiting
Berlin, Germany
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Hungary
Sanofi-Aventis Administrative Office	Recruiting
Budapest, Hungary
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Israel
Sanofi-Aventis Administrative Office	Recruiting
Natanya, Israel
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Netherlands
Sanofi-Aventis Administrative Office	Recruiting
Gouda, Netherlands
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Norway
Sanofi-Aventis Administrative Office	Recruiting
Lysaker, Norway
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Poland
Sanofi-Aventis Administrative Office	Recruiting
Warszawa, Poland
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Russian Federation
Sanofi-Aventis Administrative Office	Recruiting
Moscow, Russian Federation
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Spain
Sanofi-Aventis Administrative Office	Recruiting
Barcelona, Spain
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Sweden
Sanofi-Aventis Administrative Office	Recruiting
Bromma, Sweden
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Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Mats ERICKSSON, MD

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

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD CSD )
Study ID Numbers:	EFC6910, EudraCT: 2008-001550
Study First Received:	August 1, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00729027
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

hypercholesterolemia

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 13, 2009