Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

NCT00741715 | Terminated Phase 3

• 1 other identifier: EFC6911
• Study Type: interventional
• Target: 1,736
• Locations: 2 countries
• Sites: 2

Brief Summary

The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

Conditions

Hypercholesterolemia

Keywords

primary hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in calculated LDL-C

  At week 12

Secondary Outcomes (2)

• Percent change from baseline in calculated LDL-C

  At 6 months and 12 months

• Percent change from baseline in total cholesterol, HDL-C, TG, Apo-A1, Apo-B and CRP

  At week 12, 6 months and 12 months

Study Arms (15)

1

PLACEBO COMPARATOR

Drug: placebo

2

EXPERIMENTAL

AVE5530 25mg

Drug: AVE5530

3

EXPERIMENTAL

AVE5530 50mg

Drug: AVE5530

4

ACTIVE COMPARATOR

atorvastatin 10mg

Drug: atorvastatin

5

EXPERIMENTAL

atorvastatin 10mg + AVE5530 25mg

Drug: AVE5530; Drug: atorvastatin

6

EXPERIMENTAL

atorvastatin 10mg + AVE5530 50mg

Drug: AVE5530; Drug: atorvastatin

7

ACTIVE COMPARATOR

atorvastatin 20mg

Drug: atorvastatin

8

EXPERIMENTAL

atorvastatin 20mg + AVE5530 25mg

Drug: AVE5530; Drug: atorvastatin

9

EXPERIMENTAL

atorvastatin 20mg + AVE5530 50mg

Drug: AVE5530; Drug: atorvastatin

10

ACTIVE COMPARATOR

atorvastatin 40mg

Drug: atorvastatin

11

EXPERIMENTAL

atorvastatin 40mg + AVE5530 25mg

Drug: AVE5530; Drug: atorvastatin

12

EXPERIMENTAL

atorvastatin 40mg + AVE5530 50mg

Drug: AVE5530; Drug: atorvastatin

13

ACTIVE COMPARATOR

atorvastatin 80mg

Drug: atorvastatin

14

EXPERIMENTAL

atorvastatin 80mg + AVE5530 25mg

Drug: AVE5530; Drug: atorvastatin

15

EXPERIMENTAL

atorvastatin 80mg + AVE5530 50mg

Drug: AVE5530; Drug: atorvastatin

Interventions

AVE5530 DRUG

oral administration once daily in the evening with dinner

11; 12; 14; 15; 2; 3; 5; 6; 8; 9

atorvastatin DRUG

oral administration once daily in the evening with dinner

10; 11; 12; 13; 14; 15; 4; 5; 6; 7; 8; 9

placebo DRUG

oral administration once daily in the evening with dinner

1

Eligibility Criteria

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

You may qualify if:

• Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy

You may not qualify if:

• LDL-C levels \> 250 mg/dL (6.48 mmol/L)
• Triglycerides levels \> 350mg/dL (3.95 mmol/L)
• Conditions / situations such as:
• presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
• Active liver disease
• High estimated risk of Coronary Heart Disease
• Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
• Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
• Pregnant or breast-feeding women,
• Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
• Hypersensitivity to any component of atorvastatin
• Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin
• 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 (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Davidson Michael, MD

  Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 16, 2016

Record last verified: 2016-04

Locations

PR (1); US (1)