Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia

NCT00718965 | Terminated Phase 3

• 1 other identifier: EFC6909
• Study Type: interventional
• Target: 826
• Locations: 2 countries
• Sites: 2

Brief Summary

The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 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 and Apo-B

  at 12 weeks, 6 months and 12 months

Study Arms (3)

25 mg/day AVE5530

EXPERIMENTAL

Drug: AVE5530

50 mg/day AVE5530

EXPERIMENTAL

Drug: AVE5530

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AVE5530 DRUG

one tablet in the evening with dinner

25 mg/day AVE5530; 50 mg/day AVE5530

Placebo DRUG

one tablet in the evening with dinner

Placebo

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.
• 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

Condition Hierarchy (Ancestors)

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

Study Officials

• John CROUSE, MD

  Wake Forest University Health Sciences, North Carolina, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: May 16, 2016

Record last verified: 2016-04

Locations

PR (1); US (1)