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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00440154

Purpose

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	Intervention	Phase
Hypercholesterolemia	Drug: AVE5530 Drug: placebo Drug: ezetimibe	Phase II

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percent change in LDL-C from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change from in LDL-C levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Percent change in other lipids and lipoprotein fractions from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	206
Study Start Date:	February 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental oral administration 5 mg breakfast timing	Drug: AVE5530
2: Experimental oral administration 25 mg breakfast timing	Drug: AVE5530
3: Experimental oral administration 50 mg breakfast timing	Drug: AVE5530
4: Experimental oral administration 100 mg breakfast timing	Drug: AVE5530
5: Experimental oral administration 25 mg dinner timing	Drug: AVE5530
6: Placebo Comparator oral administration	Drug: placebo
7: Active Comparator oral administration 10mg breakfast timing	Drug: ezetimibe

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI6589, EudraCT: 2006-005469-20
Study First Received:	February 23, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00440154
Health Authority:	Chile: Instituto de Salud Publica de Chile

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Ezetimibe
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009