Hypercholesterolemia
Conditions
Brief summary
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe 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.
Detailed 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 pre-randomization phase up to 6 weeks, a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
Interventions
DRUGAVE5530
* one tablet in the evening with dinner * in addition to high doses of statin treatment
DRUGPlacebo
* one tablet in the evening with dinner * in addition to high doses of statin treatment
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.
Exclusion criteria
* LDL-C levels \> 250 mg/dL (6.48 mmol/L) or \< 100 mg/dL (2.59 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in calculated LDL-C | At week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in calculated LDL-C | At 6 months and 12 months |
| Percent change from baseline in Total-Cholesterol and Apo-B | At 12 weeks, 6 months and 12 months |
Countries
Australia, Belgium, Bulgaria, Canada, Czechia, France, Israel, Netherlands, Russia, Slovakia, South Africa, Ukraine, United States
Outcome results
None listed