Back to resultsEvaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AVE5530
atorvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring primary hypercholesterolemia
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm Type
Placebo Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Arm Description
AVE5530 25mg
AVE5530 50mg
atorvastatin 10mg
atorvastatin 10mg + AVE5530 25mg
atorvastatin 10mg + AVE5530 50mg
atorvastatin 20mg
atorvastatin 20mg + AVE5530 25mg
atorvastatin 20mg + AVE5530 50mg
atorvastatin 40mg
atorvastatin 40mg + AVE5530 25mg
atorvastatin 40mg + AVE5530 50mg
atorvastatin 80mg
atorvastatin 80mg + AVE5530 25mg
atorvastatin 80mg + AVE5530 50mg
Outcomes
Primary Outcome Measures
Percent change from baseline in calculated LDL-C
Secondary Outcome Measures
Percent change from baseline in calculated LDL-C
Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00741715
Brief Title
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
primary hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1736 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
AVE5530 25mg
Arm Title
3
Arm Type
Experimental
Arm Description
AVE5530 50mg
Arm Title
4
Arm Type
Active Comparator
Arm Description
atorvastatin 10mg
Arm Title
5
Arm Type
Experimental
Arm Description
atorvastatin 10mg + AVE5530 25mg
Arm Title
6
Arm Type
Experimental
Arm Description
atorvastatin 10mg + AVE5530 50mg
Arm Title
7
Arm Type
Active Comparator
Arm Description
atorvastatin 20mg
Arm Title
8
Arm Type
Experimental
Arm Description
atorvastatin 20mg + AVE5530 25mg
Arm Title
9
Arm Type
Experimental
Arm Description
atorvastatin 20mg + AVE5530 50mg
Arm Title
10
Arm Type
Active Comparator
Arm Description
atorvastatin 40mg
Arm Title
11
Arm Type
Experimental
Arm Description
atorvastatin 40mg + AVE5530 25mg
Arm Title
12
Arm Type
Experimental
Arm Description
atorvastatin 40mg + AVE5530 50mg
Arm Title
13
Arm Type
Active Comparator
Arm Description
atorvastatin 80mg
Arm Title
14
Arm Type
Experimental
Arm Description
atorvastatin 80mg + AVE5530 25mg
Arm Title
15
Arm Type
Experimental
Arm Description
atorvastatin 80mg + AVE5530 50mg
Intervention Type
Drug
Intervention Name(s)
AVE5530
Intervention Description
oral administration once daily in the evening with dinner
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
oral administration once daily in the evening with dinner
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration once daily in the evening with dinner
Primary Outcome Measure Information:
Title
Percent change from baseline in calculated LDL-C
Time Frame
At week 12
Secondary Outcome Measure Information:
Title
Percent change from baseline in calculated LDL-C
Time Frame
At 6 months and 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davidson Michael, MD
Organizational Affiliation
Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Puerto Rico
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia
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