Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia
This study has been terminated.
(AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00729027
First received: August 1, 2008
Last updated: November 10, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: AVE5530 Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
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 and Apo-B [ Time Frame: At 12 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 1015 |
| Study Start Date: | July 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
25 mg/day
|
Drug: AVE5530
|
|
Experimental: 2
50 mg/day
|
Drug: AVE5530
|
| Placebo Comparator: 3 |
Drug: placebo
|
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 screening phase up to 2 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729027
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Australia, New South Wales | |
| sanofi-aventis Australia & New Zealand administrative office | |
| Macquarie Park, New South Wales, Australia | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Czech Republic | |
| Sanofi-Aventis Administrative Office | |
| Praha, Czech Republic | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Horsholm, Denmark | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| Hungary | |
| Sanofi-Aventis Administrative Office | |
| Budapest, Hungary | |
| Israel | |
| Sanofi-Aventis Administrative Office | |
| Natanya, Israel | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Norway | |
| Sanofi-Aventis Administrative Office | |
| Lysaker, Norway | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Mats ERICKSSON, MD | Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Huddinge, Sweden |
More Information
No publications provided
| Responsible Party: | ICD CSD, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00729027 History of Changes |
| Other Study ID Numbers: | EFC6910, EudraCT: 2008-001550 |
| Study First Received: | August 1, 2008 |
| Last Updated: | November 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
hypercholesterolemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013