Back to resultsEvaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AVE5530
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- sanofi-aventis Australia & New Zealand administrative office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
25 mg/day AVE5530
50 mg/day AVE5530
Placebo
Arm Description
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 and Apo-B
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00766688
Brief Title
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
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
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
October 2008 (undefined)
Primary Completion Date
April 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 (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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
643 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 mg/day AVE5530
Arm Type
Experimental
Arm Title
50 mg/day AVE5530
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AVE5530
Intervention Description
one tablet in the evening with dinner
in addition to high doses of statin treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tablet in the evening with dinner
in addition to high doses of statin treatment
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 and Apo-B
Time Frame
At 12 weeks, 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
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 Australia & New Zealand administrative office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sofia
Country
Bulgaria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Brastislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
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