Estudio multicéntrico, doble ciego, randomizado, de 12 meses de duración, controlado con placebo, para evaluar el efecto hipolipemiante, la seguridad y la tolerabilidad de AVE5530 25 mg/día y 50mg/día en tratamiento concomitante con estatinas (inhibidores de la HMG-CoA reductasa) en pacientes con hipercolesterolemia primariaA multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.
- Conditions
- Hipercolesterolemia primariaPrimary HypercholesterolemiaMedDRA version: 11.0Level: LLTClassification code 10060375Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-001550-41-ES
- Lead Sponsor
- Sanofi-Aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Adult patients:
• With primary hypercholesterolemia with ongoing statin treatment at the same dose for at least 6 weeks and LDL-C levels = 100 mg/dL (2.59 mmol/L) at screening (considered insufficiently controlled)
• With 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 related to study methodology:
• Age less than 18 years at screening
• Administration of other investigational drugs within 30 days or 5 half lives prior to screening visit (Visit 1) (whichever comes the first)
• Patient who previously participated in another AVE5530 trial
• Patient who does require immediate dose escalation of statin based on investigator’s judgment
• LDL-C levels > 250 mg/dL (6.48 mmol/L)
• Triglycerides >350 mg/dL (3.95 mmol/L)
• 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 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 screening 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, CHD or CHD risk equivalents (10-year risk >20% based on Framingham risk score), Recent history (within 3 months of study screening 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 3 months of study screening, Unstable or severe peripheral artery disease within 3 months of study screening 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 ongoing statin in the preceding 6 weeks or after the screening visit.
Exclusion criteria related to AVE5530 compound:
• 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 .
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method