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A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT00440154
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : December 16, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: AVE5530 Drug: placebo Drug: ezetimibe Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
Study Start Date : February 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
oral administration 5 mg breakfast timing
Drug: AVE5530
Experimental: 2
oral administration 25 mg breakfast timing
Drug: AVE5530
Experimental: 3
oral administration 50 mg breakfast timing
Drug: AVE5530
Experimental: 4
oral administration 100 mg breakfast timing
Drug: AVE5530
Experimental: 5
oral administration 25 mg dinner timing
Drug: AVE5530
Placebo Comparator: 6
oral administration
Drug: placebo
Active Comparator: 7
oral administration 10mg breakfast timing
Drug: ezetimibe



Primary Outcome Measures :
  1. Percent change in LDL-C from baseline [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Absolute change from in LDL-C levels [ Time Frame: 4 weeks ]
  2. Percent change in other lipids and lipoprotein fractions from baseline [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
  • Male aged ≥ 18 years or postmenopausal women at screening

Exclusion Criteria:

  • Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
  • Patients with type 1 diabetes
  • Presence or history of cancer within the past five years
  • Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
  • Fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
  • Impaired kidney function and active liver disease
  • Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
  • Creatine Kinase > 2xUpper Limit of Normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440154


Locations
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00440154     History of Changes
Other Study ID Numbers: DRI6589
EudraCT: 2006-005469-20
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents