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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: ezetimibe; Drug: placebo; Drug: AVE5530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440154

EudraCT: 2006-005469-20

DRI6589

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 7 patient groups, including a placebo group

1

Experimental group

Description:

oral administration 5 mg breakfast timing

Treatment:

Drug: AVE5530

2

Experimental group

Description:

oral administration 25 mg breakfast timing

Treatment:

Drug: AVE5530

3

Experimental group

Description:

oral administration 50 mg breakfast timing

Treatment:

Drug: AVE5530

4

Experimental group

Description:

oral administration 100 mg breakfast timing

Treatment:

Drug: AVE5530

5

Experimental group

Description:

oral administration 25 mg dinner timing

Treatment:

Drug: AVE5530

6

Placebo Comparator group

Description:

oral administration

Treatment:

Drug: placebo

7

Active Comparator group

Description:

oral administration 10mg breakfast timing

Treatment:

Drug: ezetimibe