Back to resultsEvaluation of Efficacy and Safety of AVE5530 in Patients With Primary 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 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.
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 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
NCT00718965
Brief Title
Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia
Official Title
A Double-blind, Randomized, 12-month, Placebo-controlled, Parallel Group, Fixed-dose Study to Evaluate the Efficacy and Safety of AVE5530 25mg/Day and AVE5530 50 mg/Day 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
July 2008 (undefined)
Primary Completion Date
November 2008 (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 aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 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 and 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
Keywords
Primary hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
826 (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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tablet 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 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 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.
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
John CROUSE, MD
Organizational Affiliation
Wake Forest University Health Sciences, North Carolina, 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 in Patients With Primary Hypercholesterolemia
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