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

NCT00440154 | Completed Phase 2

• 2 other identifiers: DRI6589EudraCT: 2006-005469-20
• Study Type: interventional
• Target: 206
• Locations: 6 countries
• Sites: 6

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C from baseline

  4 weeks

Secondary Outcomes (2)

• Absolute change from in LDL-C levels

  4 weeks

• Percent change in other lipids and lipoprotein fractions from baseline

  4 weeks

Study Arms (7)

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

Interventions

AVE5530 DRUG

1; 2; 3; 4; 5

placebo DRUG

6

ezetimibe DRUG

7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Sanofi-Aventis Administrative Office

Santiago, Chile

Location

Sanofi-Aventis Administrative Office

Budapest, Hungary

Location

Sanofi-Aventis Administrative Office

México, Mexico

Location

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 16, 2008

Record last verified: 2008-12

Locations

KR (1); RU (1); HU (1); TU (1); ME (1); CL (1)