Primary Hypercholesterolemia MedDRA version: 11.0 Level: LLT Classification code 10060375 Term:
Conditions
Interventions
Product Code: AVE5530
Pharmaceutical Form: Film-coated tablet
CAS Number: 768394-99-6
Current Sponsor code: AVE5530
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of AVE5530 25 mg and 50 mg in add-on to ongoing stable statin on LDL-C levels over a period of 12-weeks in patients with hypercholesterolemia.;Secondary Objective: The secondary objectives of this study are: • To assess the effects of AVE5530 25 mg and 50 mg on LDL-C over 6 months and 12 months • To assess the effects of AVE5530 25 mg and 50 mg on total Cholesterol and Apolipoprotein- B (Apo-B) over 12 weeks, 6 months and 12 months • To assess the safety and tolerability of AVE5530 25 mg and 50 mg over a period of 12 weeks, 6 months and 12 months including liposoluble vitamin levels in all patients in selected centres (approximately 30% of the study population) over 12 weeks and 12 months.;Primary end point(s): Percent change from baseline (mean screening and Day 1) in calculated LDL-C at Week 12 (Visit 5- Month 3) or endpoint. Additionally, percent change from baseline (Day 1) at week 12 in LDL-C measured by ultracentrifugation will be assessed. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Hungary, Netherlands, Poland, Portugal, Spain, Sweden
Outcome results
None listed