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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00766688

Purpose

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.

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

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, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe 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:	600
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Primary Completion Date:	April 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 high doses of statin treatment
2: Experimental 50 mg/day	Drug: AVE5530 one tablet in the evening with dinner in addition to high doses of statin treatment
3: Placebo Comparator	Drug: Placebo one tablet in the evening with dinner in addition to high doses of statin treatment

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 pre-randomization phase up to 6 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 severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.

Exclusion Criteria:

LDL-C levels > 250 mg/dL (6.48 mmol/L) or < 100 mg/dL (2.59 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: NCT00766688

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Slovakia
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10841, EudraCT 2008-002849-23
Study First Received:	October 3, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00766688 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009