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

NCT ID: NCT00440154

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

oral administration 5 mg breakfast timing

Group Type EXPERIMENTAL

AVE5530

Intervention Type DRUG

2

oral administration 25 mg breakfast timing

Group Type EXPERIMENTAL

AVE5530

Intervention Type DRUG

3

oral administration 50 mg breakfast timing

Group Type EXPERIMENTAL

AVE5530

Intervention Type DRUG

4

oral administration 100 mg breakfast timing

Group Type EXPERIMENTAL

AVE5530

Intervention Type DRUG

5

oral administration 25 mg dinner timing

Group Type EXPERIMENTAL

AVE5530

Intervention Type DRUG

6

oral administration

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

7

oral administration 10mg breakfast timing

Group Type ACTIVE_COMPARATOR

ezetimibe

Intervention Type DRUG

Interventions

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AVE5530

Intervention Type DRUG

placebo

Intervention Type DRUG

ezetimibe

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Site Status

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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South Africa Chile Hungary Mexico Russia South Korea Turkey (Türkiye)

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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EudraCT: 2006-005469-20

Identifier Type: -

Identifier Source: secondary_id

DRI6589

Identifier Type: -

Identifier Source: org_study_id