Back to results

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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AVE5530

placebo

ezetimibe

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

oral administration 5 mg breakfast timing

oral administration 25 mg breakfast timing

oral administration 50 mg breakfast timing

oral administration 100 mg breakfast timing

oral administration 25 mg dinner timing

oral administration

oral administration 10mg breakfast timing

Outcomes

Primary Outcome Measures

Percent change in LDL-C from baseline

Secondary Outcome Measures

Absolute change from in LDL-C levels

Percent change in other lipids and lipoprotein fractions from baseline

Full Information

NCT ID

NCT00440154

First Posted

February 23, 2007

Last Updated

December 15, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00440154

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

oral administration 5 mg breakfast timing

Arm Title

Arm Type

Experimental

Arm Description

oral administration 25 mg breakfast timing

Arm Title

Arm Type

Experimental

Arm Description

oral administration 50 mg breakfast timing

Arm Title

Arm Type

Experimental

Arm Description

oral administration 100 mg breakfast timing

Arm Title

Arm Type

Experimental

Arm Description

oral administration 25 mg dinner timing

Arm Title

Arm Type

Placebo Comparator

Arm Description

oral administration

Arm Title

Arm Type

Active Comparator

Arm Description

oral administration 10mg breakfast timing

Intervention Type

Drug

Intervention Name(s)

AVE5530

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Type

Drug

Intervention Name(s)

ezetimibe

Primary Outcome Measure Information:

Title

Percent change in LDL-C from baseline

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Absolute change from in LDL-C levels

Time Frame

4 weeks

Title

Percent change in other lipids and lipoprotein fractions from baseline

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name