- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729027
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia
A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stable Statin Therapy (HMG-CoA Reductase Inhibitors) in Patients With Primary Hypercholesterolemia
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New South Wales
-
Macquarie Park, New South Wales, Australia
- sanofi-aventis Australia & New Zealand administrative office
-
-
-
-
-
Diegem, Belgium
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Laval, Canada
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Praha, Czech Republic
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Horsholm, Denmark
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Paris, France
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Berlin, Germany
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Budapest, Hungary
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Natanya, Israel
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Gouda, Netherlands
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Lysaker, Norway
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Warszawa, Poland
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Barcelona, Spain
- Sanofi-Aventis Administrative Office
-
-
-
-
-
Bromma, Sweden
- Sanofi-Aventis Administrative Office
-
-
-
-
New Jersey
-
Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults with cholesterol levels not controlled on ongoing stable statin treatment
Exclusion Criteria:
- LDL-C levels > 250 mg/dL (6.48 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: 25 mg/day AVE5530
|
|
Experimental: 50 mg/day AVE5530
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change from baseline in calculated LDL-C
Time Frame: At week 12
|
At week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change from baseline in calculated LDL-C
Time Frame: At 6 months and 12 months
|
At 6 months and 12 months
|
Percent change from baseline in Total-Cholesterol and Apo-B
Time Frame: At 12 weeks, 6 months and 12 months
|
At 12 weeks, 6 months and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mats ERICKSSON, MD, Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Huddinge, Sweden
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC6910
- EudraCT: 2008-001550
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Boryung Pharmaceutical Co., LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Ahn-Gook Pharmaceuticals Co.,LtdRecruitingPrimary HypercholesterolemiaKorea, Republic of
Clinical Trials on 25 mg/day AVE5530
-
University of California, San FranciscoJohns Hopkins University; Baylor College of Medicine; Children's Hospital of... and other collaboratorsNot yet recruiting
-
University of Sao Paulo General HospitalRecruitingCoronary Artery Disease | Diabetes Mellitus, Type 2 | Acute Kidney Injury | Coronary Artery Bypass SurgeryBrazil
-
ReveraGen BioPharma, Inc.National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedDuchenne Muscular DystrophyUnited States, Canada, United Kingdom, Sweden, Australia, Israel
-
ReveraGen BioPharma, Inc.University of Pittsburgh; Cooperative International Neuromuscular Research...CompletedDuchenne Muscular DystrophyUnited States, Canada, United Kingdom, Sweden, Australia, Israel
-
Zydus Lifesciences LimitedRecruitingAmyotrophic Lateral SclerosisIndia
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsCompletedInfection, Human Immunodeficiency VirusUnited States
-
University of LeipzigCompleted
-
Spectrum Pharmaceuticals, IncCompletedSafety | Phosphate Binding CapacityUnited States
-
PharmaMarApices Soluciones S.L.CompletedCOVID-19 InfectionSpain