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

This study has been terminated.
(AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00741715
First received: August 25, 2008
Last updated: November 10, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
Drug: AVE5530
Drug: atorvastatin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, "Factorial" Design, 12-month Study to Evaluate the Efficacy and Safety of AVE5530 25 mg/Day and 50 mg/Day Co-administered With All Registered Atorvastatin Strengths Ranging From 10 mg to 80 mg in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

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, HDL-C, TG, Apo-A1, Apo-B and CRP [ Time Frame: At week 12, 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 1736
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
oral administration once daily in the evening with dinner
Experimental: 2
AVE5530 25mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Experimental: 3
AVE5530 50mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Active Comparator: 4
atorvastatin 10mg
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 5
atorvastatin 10mg + AVE5530 25mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 6
atorvastatin 10mg + AVE5530 50mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Active Comparator: 7
atorvastatin 20mg
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 8
atorvastatin 20mg + AVE5530 25mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 9
atorvastatin 20mg + AVE5530 50mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Active Comparator: 10
atorvastatin 40mg
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 11
atorvastatin 40mg + AVE5530 25mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 12
atorvastatin 40mg + AVE5530 50mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Active Comparator: 13
atorvastatin 80mg
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 14
atorvastatin 80mg + AVE5530 25mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner
Experimental: 15
atorvastatin 80mg + AVE5530 50mg
Drug: AVE5530
oral administration once daily in the evening with dinner
Drug: atorvastatin
oral administration once daily in the evening with dinner

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.

  Eligibility

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

Inclusion Criteria:

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741715

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Puerto Rico
Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Davidson Michael, MD Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00741715     History of Changes
Other Study ID Numbers: EFC6911
Study First Received: August 25, 2008
Last Updated: November 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
primary hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014