A multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of AVE5530 when added to ongoing stable statin therapy at high doses in patients with severe primary hypercholesterolemia

• Conditions: Primary Hypercholesterolemia; MedDRA version: 11.0Level: LLTClassification code 10060375Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-002849-23-CZ
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

Patients can be included only if they satisfy the following criteria:
• With severe primary hypercholesterolemia and confirmed insufficient control with ongoing atorvastatin or simvastatin or rosuvastatin treatment at the highest doses (80 mg, 80 mg or 40 mg respectively) for at least 6 weeks
• With written informed consent obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria related to study methodology:
• Age less than 18 years at Visit 1
• Administration of other investigational drugs within 30 days or 5 half lives prior to Visit 1 (whichever is the longest)
• Patient who previously participated in another AVE5530 trial
• Patient who will require, in addition to ongoing atorvastatin, simvastatin or rosuvastatin treatment at the highest doses (80 mg, 80 mg or 40 mg respectively), another lipid-lowering agent (other than the study medication) in the near future, based on investigator’s judgment
• Patient in whom adjustment of the ongoing lipid lowering therapy as per protocol requirement would not be appropriate based on investigator’s judgment or who is not willing to undergo therapy adjustment
• LDL-C levels < 100 mg/dL (2.59 mmol/L)
• LDL-C levels > 250 mg/dL (6.48 mmol/L)
• Triglycerides > 350 mg/dL (3.95 mmol/L)
• Known homozygous familial hypercholesterolemia
• Conditions / situations such as:
- Patients with conditions/concomitant diseases
- Making them non-evaluable for the primary efficacy endpoint: such as presence of any clinically significant and not controlled endocrine disease known to influence serum lipids or lipoproteins. Patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for at least 3 months prior to Visit 1 and their s- TSH (sensitive TSH) levels is within ±10% of the normal ranges of the Central
Laboratory.
- Any conditions considered to be medically sound by the investigator that would limit the patient’s safe participation in the study such as:
- Active liver disease, as shown by but not limited to alanine aminotransferase
(ALT) or aspartate amino-transferase (AST) = 3xUpper Limit Normal (ULN) range
- Neutrophils < 1,500/mm3
- Platelets counts < 100 000/ mm3
- Unexplained CPK = 3xULN
- Recent history (within 6 months of Visit 1 and through to randomization) of
moderate or severe congestive heart failure [New York Heart Association (NYHA)Class III or IV]
- Recent history of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty within 6 months of study screening,
- Unstable or severe peripheral artery disease within 6 months of Visit 1 and through to randomization
- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
- Known to be Human Immunodeficiency Virus (HIV) positive
- Presence of any other conditions (e.g. geographic, social….) actual or anticipated that the investigator feels would restrict or limit the patient’s participation for the duration of the study
- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Administration of any lipid-lowering treatment other than the background statins allowed for the study (atorvastatin 80 mg, simvastatin 80 mg or rosuvastatin 40 mg)
after visit 1.

Exclusion criteria related to AVE5530 compound:
• Pregnant or breast-feeding women,
• Women of childbearing potential not protected by effective 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified