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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: AVE5530; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718965

EFC6909

Details and patient eligibility

About

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.

Full description

The study will include a 2-week pre-randomization placebo lead-in phase and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Enrollment: 826 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

826 participants in 3 patient groups, including a placebo group

25 mg/day AVE5530

Experimental group

Treatment:

Drug: AVE5530

50 mg/day AVE5530

Experimental group

Treatment:

Drug: AVE5530

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo