Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: 25 mg/day AVE5530; Drug: 50 mg/day AVE5530; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729027

EudraCT: 2008-001550

EFC6910

Details and patient eligibility

About

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.

The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Full description

The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a screening phase up to 2 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.

Enrollment: 1,015 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with cholesterol levels not controlled on ongoing stable statin treatment

Exclusion criteria

• LDL-C levels > 250 mg/dL (6.48 mmol/L)

• Triglycerides >350 mg/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
  • 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

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1,015 participants in 3 patient groups, including a placebo group

25 mg/day AVE5530

Experimental group

Treatment:

Drug: 25 mg/day AVE5530

50 mg/day AVE5530

Experimental group

Treatment:

Drug: 50 mg/day AVE5530

Placebo

Placebo Comparator group

Treatment:

Drug: placebo